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Clinical Data

BETTER EVIDENCE TO BUILD CONFIDENCE

Abbott provides a robust body of clinical evidence encompassing clinical data and outcomes from tens of thousands of patients across our structural heart portfolio of products.*

IN-DEPTH DATA ABOUT ABBOTT STRUCTURAL HEART PRODUCTS

With our Clinical Insights and Bulletins you can take a deeper dive into clinical outcomes related to Abbott Structural Heart products. Designed for ease of viewing, these pieces give you a broader perspective about study outcomes along with product safety and performance.

  • Follow-up study with 15-year data for the Epic Mitral Valve compared to Magna Mitral Ease
    EPIC™ MITRAL STENTED TISSUE VALVE WITH LINX™ AC TECHNOLOGY

    Reported 15-Year Data: The Epic™ Mitral and the Magna Mitral Ease Platforms‡

    Read more
  • Clinical studies find consistent durability in Epic Mitral Valve tested over 35 years
    EPIC™ MITRAL STENTED TISSUE VALVE WITH LINX™ AC TECHNOLOGY

    Epic™ Mitral Continues the Biocor™ Legacy: Strength of Design, Tested Over 35 Years1

    Read more
  • Clinical evidence for recurrent stroke risk reduction with the Amplatzer PFO Occluder
    AMPLATZER™ PFO OCCLUDER

    Clinical Evidence for Recurrent Stroke Risk Reduction with the Amplatzer™ PFO Occluder

    Read more
  • Hemodynamic Monitoring during MitraClip™ Procedures
    MITRACLIP™ FOR TMVr**

    Hemodynamic Monitoring during MitraClip™ Procedures

    Read more
  • Cardiovascular Physiology in Mitral Regurgitation
    MITRACLIP™ FOR TMVr

    Cardiovascular Physiology in Mitral Regurgitation

    Read more
  • Amplatzer Atrial Septal Occluder clinical data update
    AMPLATZER™ ATRIAL SEPTAL OCCLUDER

    Amplatzer™ Atrial Septal Occluder Clinical Data Update

    Read more
  • Advantages of the Intaglio wire treatment of the Amplatzer Occluders
    AMPLATZER™ INTAGLIO™ WIRE TREATMENT

    Advantages of the Intaglio™ wire treatment of the Amplatzer™ Occluders

    Read more

MAT-2116292 v1.0 | Item approved for U.S. use only.

References

*Data on File at Abbott
**TMVr is now referred to as TEER (Transcatheter edge-to-edge repair)

1. Mykén, P. S. U., & Bech-Hansen, O. (2009). A 20-year experience of 1712 patients with the Biocor porcine bioprosthesis. The Journal of Thoracic and Cardiovascular Surgery, 137(1), 76–81. doi.org/10.1016/j.jtcvs.2008.05.068

Important Safety Information
  • MitraClip
  • Epic PLUS
  • Trifecta GT
  • Masters Series
  • Regent
  • Amplatzer Amulet
  • Amplatzer Talisman PFO
  • Amplatzer Septal Occluder
  • Amplatzer VSD Occluders
  • Amplatzer Piccolo Occluders
  • Amplatzer Duct Occluders

  • MITRACLIP DELIVERY SYSTEMS
    INDICATION FOR USE
     

    • The MitraClip™ G4 System is indicated for the percutaneous reduction of significant symptomatic mitral regurgitation (MR ≥ 3+) due to primary abnormality of the mitral apparatus [degenerative MR] in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, and in whom existing comorbidities would not preclude the expected benefit from reduction of the mitral regurgitation.
    • The MitraClip™ G4 System, when used with maximally tolerated guideline-directed medical therapy (GDMT), is indicated for the treatment of symptomatic, moderate-to-severe or severe secondary (or functional) mitral regurgitation (MR; MR ≥ Grade III  per American Society of Echocardiography criteria) in patients with a left ventricular ejection fraction (LVEF) ≥ 20% and ≤ 50%, and a left ventricular end systolic dimension (LVESD) ≤ 70 mm whose symptoms and MR severity persist despite maximally tolerated GDMT as determined by a multidisciplinary heart team experienced in the evaluation and treatment of heart failure and mitral valve disease.

    CONTRAINDICATIONS

    The MitraClip™ G4 System is contraindicated in patients with the following conditions:

    • Patients who cannot tolerate, including allergy or hypersensitivity to, procedural anticoagulation or post procedural anti-platelet regimen
    • Patients with known hypersensitivity to clip components (nickel / titanium, cobalt, chromium, polyester), or with contrast sensitivity
    • Active endocarditis of the mitral valve
    • Rheumatic mitral valve disease
    • Evidence of intracardiac, inferior vena cava (IVC) or femoral venous thrombus

    WARNINGS

    • DO NOT use MitraClip™ outside of the labeled indication.
    • The MitraClip™ G4 Implant should be implanted with sterile techniques using fluoroscopy and echocardiography (e.g. transesophageal [TEE] and transthoracic [TTE]) in a facility with on-site cardiac surgery and immediate access to a cardiac operating room.
    • Read all instructions carefully. Use universal precautions for biohazards and sharps while handling the MitraClip™ G4 System to avoid user injury. Failure to follow these instructions, warnings and precautions may lead to device damage, user injury or patient injury including:
      • MitraClip™ G4 Implant erosion, migration or malposition
      • Failure to deliver MitraClip™ G4 Implant to the  intended site
      • Difficulty or failure to retrieve MitraClip™ G4 system components
    • Use caution when treating patients with hemodynamic instability requiring inotropic support or mechanical heart assistance due to the increased risk of mortality in this patient population. The safety and effectiveness of MitraClip™ in these patients has not been evaluated.
    • Patients with a rotated heart due to prior cardiac surgery in whom the System is used may have a potential risk of experiencing adverse events such as atrial perforation, cardiac tamponade, tissue damage, and embolism which may be avoided with preoperative evaluation and proper device usage.
    • For the Steerable Guide Catheter and Delivery Catheter only:
      • The Guide Catheter: the distal 65 cm of the Steerable Guide Catheter with the exception of the distal soft tip, is coated with a hydrophilic coating.
      • The Delivery Catheter: coated with a hydrophilic coating for a length of approximately 131 cm.
      • Failure to prepare the device as stated in these instructions and failure to handle the device with  care could lead to additional intervention or serious adverse event.
    • The Clip Delivery System is provided sterile and designed for single use only. Cleaning, re-sterilization and / or re-use may result in infections, malfunction of the device and other serious injury or death.
    • Note the product “Use by“ date specified on the package.
    • Inspect all product prior to use. Do not use if the package is open or damaged, or if product is damaged.

    PRECAUTIONS

    • Prohibitive Risk Primary (or degenerative) Mitral Regurgitation
      • Prohibitive risk is determined by the clinical judgment of a heart team, including a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, due to the presence of one or more of the following documented surgical risk factors:
        • 30-day STS predicted operative mortality risk score of
          • ≥8% for patients deemed likely to undergo mitral valve replacement or
          • ≥6% for patients deemed likely to undergo mitral valve repair
      • Porcelain aorta or extensively calcifed ascending aorta.
      • Frailty (assessed by in-person cardiac surgeon consultation)
      • Hostile chest
      • Severe liver disease / cirrhosis (MELD Score > 12)
      • Severe pulmonary hypertension (systolic pulmonary artery pressure > 2/3 systemic pressure)
      • Unusual extenuating circumstance, such as right ventricular dysfunction with severe tricuspid regurgitation, chemotherapy for malignancy, major bleeding diathesis, immobility, AIDS, severe dementia, high risk of aspiration, internal mammary artery (IMA) at high risk of injury, etc.
      • Evaluable data regarding safety or effectiveness is not available for prohibitive risk Primary patients with an LVEF < 20% or an LVESD > 60 mm. MitraClip™ should be used only when criteria for clip suitability for Primary have been met.
      • The heart team should include a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease and may also include appropriate physicians to assess the adequacy of heart failure treatment and valvular anatomy.
    • Secondary Mitral Regurgitation
      • Evaluable data regarding safety or effectiveness is not available for secondary MR patients with an LVEF < 20% or an LVESD > 70 mm.
      • The multidisciplinary heart team should be experienced in the evaluation and treatment of heart failure and mitral valve disease and determine that symptoms and MR severity persist despite maximally tolerated GDMT.

    POTENTIAL COMPLICATIONS AND ADVERSE EVENTS

    The following ANTICIPATED EVENTS have been identified as possible complications of the MitraClip™ G4 procedure.

    • Allergic reactions or hypersensitivity to latex, contrast agent, anaesthesia, device materials (nickel / titanium, cobalt, chromium, polyester), and drug reactions to anticoagulation, or antiplatelet drugs
    • Vascular access complications which may require transfusion or vessel repair including:
      • wound dehiscence
      • catheter site reactions
      • Bleeding (including ecchymosis, oozing, hematoma, hemorrhage, retroperitoneal hemorrhage)
      • Arteriovenous fistula, pseudoaneurysm, aneurysm, dissection, perforation / rupture, vascular occlusion
      • Emboli (air thrombotic material, implant, device component)
      • Peripheral Nerve Injury
    • Lymphatic complications
    • Pericardial complications which may require additional intervention, including:
      • Pericardial effusion
      • Cardiac tamponade
      • Pericarditis
    • Cardiac complications which may require additional interventions or emergency cardiac surgery, including:
      • Cardiac perforation
      • Atrial septal defect
    • Mitral valve complications, which may complicate or prevent later surgical repair, including:
      • Chordal entanglement / rupture
      • Single Leaflet Device Attachment (SLDA)
      • Thrombosis
      • Dislodgement of previously implanted devices
      • Tissue damage
      • Mitral valve stenosis
      • Persistent or residual mitral regurgitation
      • Endocarditis
    • Cardiac arrhythmias (including conduction disorders, atrial arrhythmias, ventricular arrhythmias)
    • Cardiac ischemic conditions (including myocardial infarction, myocardial ischemia, and unstable / stable angina)
    • Venous thromboembolism (including deep vein thrombosis, pulmonary embolism, post procedure pulmonary embolism)
    • Stroke / Cerebrovascular accident (CVA) and Transient Ischemic Attack (TIA)
    • System organ failure:
      • Cardio-respiratory arrest
      • Worsening heart failure
      • Pulmonary congestion
      • Respiratory dysfunction / failure / atelectasis
      • Renal insufficiency or failure
      • Shock (including cardiogenic and anaphylactic)
    • Blood cell disorders (including coagulopathy, hemolysis, and Heparin Induced Thrombocytopenia (HIT))
    • Hypotension / hypertension
    • Infection including:
      • Urinary Tract Infection (UTI)
      • Pneumonia
      • Septicemia
    • Nausea / vomiting
    • Chest pain
    • Dyspnea
    • Edema
    • Fever or hyperthermia
    • Pain
    • Death
    • Fluoroscopy, Transesophageal echocardiogram (TEE) and Transthoracic echocardiogram (TTE) -related complications:
      • Skin injury or tissue changes due to exposure to  ionizing radiation
      • Esophageal irritation
      • Esophageal perforation
      • Gastrointestinal bleeding

  • EPICTM PLUS/ EPICTM PLUS SUPRA STENTED PORCINE TISSUE VALVES
    INDICATION FOR USE


    The Epic™ Plus valve is indicated for patients requiring replacement of a diseased, damaged, or malfunctioning native aortic and/or mitral heart valve. It may also be used as a replacement for a previously implanted aortic and/or mitral prosthetic heart valve.
    The Epic™ Plus Supra valve is indicated for patients requiring replacement of a diseased, damaged, or malfunctioning native aortic heart valve. It may also be used as a replacement for a previously implanted aortic prosthetic heart valve.

    CONTRAINDICATIONS

    None known.

    WARNINGS

    • Valve size selection is based on the size of the recipient annulus, and for supra-annular aortic placement, the anatomy of the sinotubular space. Implantation of an inappropriately large bioprosthesis may result in stent deformation, valvular incompetence, valve damage, diminished tissue durability and/or damage to the surrounding tissues. The use of an inappropriately small bioprosthesis may result in suboptimal hemodynamics. Use only the E2000 Epic™ Plus Heart Valve Sizer Set with the Epic™ Plus and Epic™ Plus Supra valves.
    • Accelerated deterioration due to calcific degeneration of the Epic Plus and Epic Plus Supra valve may occur in:
      • children, adolescents, or young adults;
      • patients with altered calcium metabolism (e.g., patients with hyperparathyroidism or chronic renal failure); or
      • individuals requiring hemodialysis.
    • For single use only. Do not reuse or resterilize. Attempts to resterilize the valve may result in valve malfunction, inadequate sterilization, or patient harm.
    • Passage of a catheter or transvenous pacing lead through any bioprosthesis may damage the valve and is therefore not recommended.
    • Do not use if:
      • the valve has been dropped, damaged, or mishandled in any way, or if there is any sign of deterioration;
      • the expiration date has elapsed;
      • the tamper-evident container seal is damaged, broken, or missing, or if fluid is leaking from the packaging; or
      • the storage solution does not completely cover the valve.

    PRECAUTIONS

    • The safety and effectiveness of the Epic™ Plus and Epic™ Plus Supra valves has not been established for the following specific populations:
      • patients who are pregnant
      • nursing mothers
      • patients with chronic renal failure
      • patients with aneurysmal aortic degenerative conditions (e.g., cystic medial necrosis, Marfan’s syndrome)
      • patients with chronic endocarditis
      • patients requiring pulmonic or tricuspid valve replacement
      • children, adolescents, or young adults
    • Sizers are supplied non-sterile, and must be cleaned and sterilized prior to each use. Do not use cracked, deformed, or damaged sizer set components.
    • Do not pass the flanged portion of the valve replica sizing tool through the annulus.
    • Do not place the non-sterile exterior of the valve container in the sterile field.
    • Do not expose the valve to solutions other than the formaldehyde valve storage solution in which it was shipped, the sterile isotonic saline solution used during the rinsing procedure, or the sterile isotonic saline solution used to irrigate the valve.
    • Do not add antibiotics to either the formaldehyde valve storage solution or the rinse solution.
    • Do not apply antibiotics to the valve.
    • Do not allow the valve tissue to dry. Place the valve in sterile isotonic saline rinse solution immediately upon removal from the valve storage solution. Once removed from this solution, the valve should be periodically irrigated during implantation.
    • Do not use the valve if shipping temperature indicators on the product carton have turned red, or if the valve has been improperly stored in temperature conditions outside of the 5 °C to 25 °C range.
    • Do not implant the valve without thoroughly rinsing as directed.
    • Do not lacerate the valve tissue. If a valve is damaged, the valve must be explanted and replaced.
    • Do not attempt to repair a valve. Damaged valves must not be used.
    • Do not use cutting edge needles, unprotected forceps, or sharp instruments as they may cause structural damage to valve.
    • Never handle the leaflet tissue.
    • Position the mitral valve in a manner to avoid commissure obstruction of the left ventricular outflow tract, and minimize any potential of commissure contact with the ventricular wall.
    • Position the aortic valve so that the stent posts do not obstruct the coronary ostia or come in direct contact with the aortic wall.
    • When implanting the Epic™ Plus heart valve, assess the suitability of the selected valve size and stent post position for a potential future valve-in-valve procedure and whether the transcatheter valve-in-valve procedure may result in left ventricular outflow tract or coronary ostia obstruction. For future valve-in-valve procedure in an Epic Plus valve, refer to the instructions for use supplied with the transcatheter heart valve along with reference dimensions in Table 1 (in the IFU) to determine compatibility. The safety and effectiveness of valve-in-valve procedures in an Epic™ Plus or an Epic™ Plus Supra valve have not been established.
    • Avoid prolonged contact with the formaldehyde storage solution. Immediately after contact, thoroughly flush any skin exposed to the solution with water. In case of contact with eyes, flush with water and seek appropriate medical care.

    ADVERSE EVENTS

    The clinical investigation of the Epic valve supports the safety and effectiveness of the Epic™ Plus valve and the Epic™ Plus Supra valve. Between January 2003 and March 2006, seven-hundred and sixty-two (762) subjects were implanted with 791 Epic Valve(s) at 19 investigational sites in the United States (U.S.), and three sites in Canada. Five-hundred and fifty-seven (557) subjects received isolated aortic replacement, 176 received isolated mitral replacement, and 29 received replacement of both the aortic and mitral valves. The cumulative follow-up for all subjects was 773.51 patient-years with a mean follow-up of 1.02 patient-years (s.d. = 0.71 patient-years, range 0 – 3.10 patient-years).

    Potential Adverse Events

    Adverse events potentially associated with the use of bioprosthesis heart valves (in alphabetical order) include: 

    • angina
    • cardiac arrhythmias
    • endocarditis
    • heart failure
    • hemolysis
    • hemolytic anemia
    • hemorrhage, anticoagulant/antiplatelet-related
    • leak, transvalvular or paravalvular
    • myocardial infarction
    • nonstructural dysfunction (entrapment by pannus or suture, inappropriate sizing or positioning, or other)
    • prosthesis regurgitation
    • stroke
    • structural deterioration (calcification, leaflet tear, or other)
    •  thromboembolism
    •  valve thrombosis

    It is possible that these complications could lead to:

    •  reoperation
    •  explantation
    •  permanent disability
    •  death

  • TRIFECTATM VALVE WITH GLIDETM TECHNOLOGY (GT)
    INDICATION FOR USE


    The TrifectaTM Valve with GlideTM Technology is intended as a replacement for a diseased, damaged, or malfunctioning native or prosthetic aortic heart valve.

    CONTRAINDICATIONS

    None known.

    WARNINGS

    • For single use only. Do not reuse or resterilize. Attempts to resterilize the valve may result in valve malfunction, inadequate sterilization, or patient harm.
    • Do not oversize. Valve size selection is based on the size of the recipient annulus and the anatomy of the sinotubular junction. If the native annulus measurement falls between the two valve sizes, use the smaller size valve. Use only the Model TF2000 Trifecta Sizers for sizing the valve. Implantation of an oversized valve may result in stent deformation, valvular incompetence, valve damage, diminished tissue durability, and/or damage to the surrounding tissues.
    • Passage of a diagnostic catheter or transvenous pacing lead through any bioprosthesis may damage the valve and is therefore not recommended.
    • Accelerated deterioration of the valve may occur in:
      • Children, adolescents, or young adults
      • Patients with altered calcium metabolism (e.g., patients with hyperparathyroidism or chronic renal failure)
      • Individuals requiring hemodialysis
    • Do not use if:
      • The valve has been dropped, damaged, or mishandled in any way, or if there is any sign of deterioration.
      • The expiration date has elapsed.
      • The tamper-evident jar seal is damaged, broken, or missing or if fluid is leaking from the packaging.
      • The storage solution does not completely cover the valve.
    • Use only the TrifectaTM Model TF2000 sizers1 for sizing the valve.
    • The titanium valve stent is not designed as a flexible stent. Do not bend the titanium valve stent. Deformation of the stent may impair valve function.

    PRECAUTIONS

    • Safety and effectiveness of the valve has not been established for the following specific populations:
      • Patients who are pregnant
      • Nursing mothers
      • Patients with chronic renal failure
      • Patients with aneurysmal aortic degenerative conditions (e.g., cystic medial necrosis, Marfan’s syndrome)
      • Patients with chronic endocarditis
      • Patients requiring pulmonic or tricuspid valve replacement
      • Children, adolescents, or young adults
    • Sizer sets are supplied non-sterile, and must be cleaned and sterilized prior to each use. Do not use cracked, crazed, or deformed sizer set components.
    • Do not place the non-sterile exterior of the valve jar in the sterile field.
    • Do not use the valve if shipping temperature indicators on the product carton have turned red, or if the valve has been improperly stored in temperature conditions outside of the 5°C–25°C (41°F–77°F) range.
    • Do not expose the valve to solutions other than the formaldehyde solution in which it was shipped,  the sterile isotonic saline solution used during the rinsing procedure, or the sterile isotonic saline  used to irrigate the valve.
    • Do not add antibiotics to either the valve storage solution or the rinse solution.
    • Do not apply antibiotics to the valve.
    • Do not allow the valve tissue to dry. Place the valve in isotonic sterile saline rinse solution immediately upon removal from the valve storage solution. Once removed from this solution, the valve should be periodically irrigated during implantation.
    • Do not implant the valve without thoroughly rinsing as directed.
    • Position the valve so that the stent posts do not obstruct the coronary ostia or come in direct contact with the aortic wall.
    • Never handle the leaflet tissue.
    • Avoid prolonged contact with the formaldehyde storage solution. Immediately after contact,  thoroughly flush any skin exposed to the solution with water. In case of contact with eyes flush with water and seek appropriate medical care.
    • Use caution when placing sutures through the  sewing cuff to avoid lacerating the valve tissue.  If a valve is damaged, the valve must be replaced.
    • Do not use cutting edge needles, unprotected forceps, or sharp instruments, as they may cause structural damage to the valve.
    • Do not attempt to repair a valve. Damaged valves must not be used.
    • Do not pass the replica end of the TF2000 sizer through the annulus when sizing the valve.
    • Use caution when tying knots to avoid bending  the stent posts.

    ADVERSE EVENTS

    The TrifectaTM Valve with GlideTM Technology is based upon the TrifectaTM Valve design. Therefore, a previous clinical investigation of the TrifectaTM Valve supports the safety of the TrifectaTM Valve with GlideTM Technology. Between June 2007 and November 2009, one thousand and twenty-two (1022) subjects were implanted with the Trifecta valve in the aortic position at 31 investigational sites in the United States (18), Canada (7), and Europe (6). Data are presented on the one thousand and fourteen (1014) subjects who met eligibility criteria. The cumulative follow-up for all subjects was 924.18 patient-years with a mean follow-up of 0.91 years (SD = 0.49 years, range 0 - 2.38 years).

    Adverse events potentially associated with the use of bioprosthetic heart valves include:

    • angina
    • cardiac arrhythmias
    • endocarditis
    • heart failure
    • hemolysis
    • hemolytic anemia 
    • hemorrhage
    • leak, transvalvular or paravalvular
    • myocardial infarction
    • nonstructural dysfunction (entrapment by pannus or suture, inappropriate sizing or positioning, or other)
    • prosthesis regurgitation
    • stroke
    • structural deterioration (calcification, leaflet tear, or other)
    • thromboembolism
    • valve thrombosis

    It is possible that these complications could lead to:

    • reoperation
    • explantation
    • permanent disability
    • death

    See the Clinical Study section of these instructions for adverse event data collected in the TrifectaTM Valve clinical investigation.

    1. TF2000 sizers are included in sizer set models TF2000 and TF2000-2.

  • SJM™ MASTERS SERIES
    MECHANICAL HEART VALVE


    The SJM™ Masters Series Mechanical Heart Valve is intended for use as a replacement valve in patients with a diseased, damaged, or malfunctioning aortic or mitral heart valve. This device may also be used to replace a previously implanted prosthetic heart valve.

    CONTRAINDICATIONS

    The SJM™ Masters Series Mechanical Heart Valve is contraindicated for individuals unable to tolerate anticoagulation therapy.

    WARNINGS

    • For single use only. Attempts to reuse the valve may result in valve malfunction, inadequate sterilization, or patient harm.
    • Do not use if:
      • The valve has been dropped, damaged, or mishandled in any way.
      • The expiration date has elapsed.
      • The tamper-evident container seal or inner/outer tray seals are damaged, broken or missing.
    • Remove any residual tissue that may impair valve size selection, correct seating of the valve, rotation of the valve, or leaflet motion.
    • Proper valve size selection is crucial. Do not oversize the valve. If the native annulus measurement falls between two SJM™ Masters Series Mechanical Heart Valve sizes, use the smaller size SJM™ Masters Series Mechanical Heart Valve.
    • Use only St. Jude Medical™ mechanical heart valve sizers.
    • The outer tray is not sterile, and should not be placed in the sterile field.
    • To minimize direct handling of the valve during implantation, do not remove the holder/rotator until the valve has been seated in the annulus.
    • Do not use hard or rigid instruments to test leaflet mobility, as this may result in structural damage to the valve or thromboembolic complications. Use a St. Jude Medical™ leaflet tester to gently test valve leaflet mobility.
    • Place sutures in the outer half of the valve sewing cuff.
    • Never apply force to the valve leaflets. Force may cause structural damage to the valve.
    • Use only SJM™ Valve Holder/Rotators to perform valve rotation. Use of other instruments could result in structural damage. The valve holder/ rotator is intended for single use only and should be discarded after surgery.
    • The two retention sutures on the valve holder/ rotator must be cut and removed before the SJM™ Masters Series Mechanical Heart Valve can be rotated.
    • Do not pass catheters or other instruments through St. Jude Medical™ mechanical heart valves. This could result in scratched or damaged valve components, or leaflet fracture or dislodgment.
    • Cut suture ends short, especially in the vicinity of the pivot guards, to prevent leaflet impingement.
    • Three cases of impeded leaflet motion not satisfactorily explained were reported in a survey of 149 centers reporting on 4,934 patients implanted over a period of three (3) years. A number of other cases occurred early in the investigation of this prosthesis; however, the rates of occurrence are not statistically determinable.

    PRECAUTIONS

    • Do not touch the prosthetic valve unnecessarily, even with gloved hands. This may cause scratches or surface imperfections that may lead to thrombus formation.
    • Be careful not to cut or tear the valve sewing cuff when removing the identification tag and the holder/rotator from the SJM™ Masters Series Mechanical Heart Valve.
    • Before placing sutures in the valve sewing cuff, verify that the valve is mounted correctly on the valve holder/rotator.
    • To avoid structural damage, the valve must be rotated in the fully closed position.
    • To minimize rotational torque, verify that the valve holder/rotator is properly seated in the valve, and that the valve holder handle is perpendicular to the valve (Figures 15a and 15b).
    • Remove any loose suture or thread, which may be a source of thrombus or thromboembolism.

    POTENTIAL ADVERSE EVENTS

    Complications associated with replacement mechanical heart valves include, but are not limited to:

    hemolysis; infections; thrombus; or thromboembolism; valve dehiscence; unacceptable hemodynamic performance; hemorrhagic complications secondary to anticoagulation therapy; prosthetic failure; and heart failure or death.

    Any of these complications may require reoperation or explantation of the device.

  • SJM REGENTTM MECHANICAL HEART VALVE
    INDICATION FOR USE


    The SJM RegentTM Mechanical Heart Valve is intended for use as a replacement valve in patients with a diseased, damaged, or malfunctioning aortic valve. This device may also be used to replace a previously implanted aortic prosthetic heart valve.

    CONTRAINDICATIONS

    The SJM RegentTM Mechanical Heart Valve is contraindicated for individuals unable to tolerate anticoagulation therapy.

    WARNINGS

    • For single use only. Attempts to reuse the valve may result in valve malfunction, inadequate sterilization, or patient harm.
    • Do not use if:
      • The valve has been dropped, damaged, or mishandled in any way.
      • The expiration date has elapsed.
      • The tamper-evident container seal or inner/outer tray seals are damaged, broken or missing.
    • Remove any residual tissue that may impair valve size selection, correct seating of the valve, rotation of the valve, or leaflet motion.
    • Proper valve size selection is crucial. Do not oversize the valve. If the native annulus measurement falls between two SJM RegentTM Mechanical Heart Valve sizes, use the smaller size SJM RegentTM Mechanical Heart Valve.
    • Use only St. Jude MedicalTM mechanical heart valve sizers.
    • The outer tray is not sterile, and should not be placed in the sterile field.
    • To minimize direct handling of the valve during implantation, do not remove the holder/rotator until the valve has been seated in the annulus.
    • Do not use hard or rigid instruments to test leaflet mobility, as this may result in structural damage to the valve or thromboembolic complications. Use a St. Jude MedicalTM leaflet tester to gently test valve leaflet mobility.
    • Do not use cutting edge needles in the sewing cuff. If use of these needles is necessary, placement of sutures in the outer half of the sewing cuff is imperative.
    • Never apply force to the valve leaflets. Force may cause structural damage to the valve.
    • Use only the valve holder/rotator packaged with the SJM RegentTM Mechanical Heart Valve to perform valve rotation. Use of other instruments could result in structural damage. The valve holder/ rotator is intended for single use only and should be discarded after surgery.
    • The two retention sutures on the valve holder/ rotator must be cut and removed before the SJM RegentTM Mechanical Heart Valve can be rotated.
    • Do not pass catheters or other instruments through St. Jude MedicalTM mechanical heart valves. This could result in scratched or damaged valve components, or leaflet fracture or dislodgment.
    • Cut suture ends short, especially in the vicinity of the pivot guards, to prevent leaflet impingement.

    PRECAUTIONS

    • Do not touch the prosthetic valve unnecessarily, even with gloved hands. This may cause scratches or surface imperfections that may lead to thrombus formation.
    • Be careful not to cut or tear the valve sewing cuff when removing the identification tag and the holder/rotator from the SJM RegentTM Mechanical Heart Valve.
    • Before placing sutures in the valve cuff, verify that the valve is mounted correctly on the valve holder/rotator.
    • To avoid structural damage, the valve must be rotated in the fully closed position.
    • To minimize rotational torque, verify that the valve holder/rotator is properly seated in the valve, and that the valve holder handle is perpendicular to the valve (Figures 15a and 15b).
    • Remove any loose suture or thread, which may be a source of thrombus or thromboembolism.

    POTENTIAL ADVERSE EVENTS

    Complications associated with replacement mechanical heart valves include, but are not limited to:

    hemolysis; infections; thrombus; or thromboembolism; valve dehiscence; unacceptable hemodynamic performance; hemorrhagic complications secondary to anticoagulation therapy; prosthetic failure; and heart failure or death.

    Any of these complications may require reoperation or explantation of the device.

  • AMPLATZER™ AMULET™ LEFT ATRIAL APPENDAGE OCCLUDER
    INDICATION FOR USE

    The Amplatzer™ Amulet™ Left Atrial Appendage Occluder is a percutaneous transcatheter device intended to reduce the risk of thrombus embolization from the left atrial appendage (LAA) in patients who have nonvalvular atrial fibrillation and who are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores, are suitable for short term anticoagulation therapy, and have appropriate rationale to seek a non-pharmacologic alternative to oral anticoagulation, taking into consideration the safety and effectiveness of the device.

    CONTRAINDICATIONS

    The Amplatzer™ Amulet™ Left Atrial Appendage (LAA) Occluder is contraindicated for patients:

    • with the presence of intracardiac thrombus,
    • with active endocarditis or other infections producing bacteremia.
    • where placement of the device would interfere with any intracardiac or intravascular structures.

    WARNINGS

    •  If the device is retracted while it is in the sheath, the device and the sheath must both be removed and replaced. Failure to replace both the device and the sheath may result in sheath and/or device malfunction.
    • If the device is retracted farther than the radiopaque markers (fully recaptured), the device and the sheath must both be removed and replaced. Failure to replace both the device and the sheath may result in sheath and/or device malfunction.
    • Physicians must be prepared to deal with urgent situations, such as pericardial effusion or device embolization, which can require removal of the device.
    • This device should be used only by physicians who are trained in standard transcatheter techniques. The physician should determine which patients are candidates for procedures that use this device.
    • Late pericardial effusion events were observed in the clinical study. The use of post-procedure anticoagulation therapy may be associated with an increased potential for a late pericardial effusion. Physicians should monitor for signs and symptoms of pericardial effusion and obtain appropriate imaging when indicated. Physicians should also consider routine echocardiography to screen for pericardial effusion.
    • Remove embolized devices. Do not remove an embolized device unless the device is fully captured inside a sheath.
    • The Amplatzer™ Amulet™ device contains a nickeltitanium alloy, which is generally considered safe. However, in vitro testing has demonstrated that nickel is released from this device for a minimum of 120 days. Patients who are allergic to nickel may have an allergic reaction to this device, especially those with a history of metal allergies. Certain allergic reactions can be serious; patients should be instructed to seek medical assistance immediately if they suspect they are experiencing an allergic reaction. Symptoms may include difficulty in breathing or swelling of the face or throat. While data are currently limited, it is possible that some patients may develop an allergy to nickel if this device is implanted.
    • Do not use this device if the sterile package is open or damaged.
    • The device was sterilized with ethylene oxide and is for single use only. Do not reuse or resterilize this device. Attempts to resterilize this device can cause a malfunction, insufficient sterilization, or harm to the patient.
    • Use on or before the expiration date that is printed on the product packaging label.

    PRECAUTIONS

    • The physician should exercise clinical judgment in situations that involve the use of antithrombotic drugs before, during, and/or after the use of this device.
    • The physician should exercise caution if implanting a device in a patient who has an implantable cardioverter defibrillator (ICD) or pacemaker leads.
    • The physician should have the guidewire in the left upper pulmonary vein when making exchanges in the left atrium.
    • Ensure that the vasculature is adequate for the sheath size being selected.
    • The physician should exercise caution if performing ablation at or near the implant site after the device is implanted.
    • Use standard interventional cardiovascular catheterization techniques when using Amplatzer™ products.
    • Use in specific populations
      • Pregnancy – Minimize the radiation exposure to the fetus and the mother.
      • Nursing mothers – There has been no quantitative assessment for the presence of leachables in breast milk.

    MRI SAFETY INFORMATION 

    Non-clinical testing has demonstrated that the Amplatzer™ Amulet™ Left Atrial Appendage Occluder device is MR Conditional. A patient with the Amplatzer™Amulet™ device can be safely scanned in an MR system under the following conditions:

    • Static magnetic fields of 1.5 Tesla (1.5T) and 3.0 Tesla (3.0T)
    • Maximum spatial gradient field of 19 T/m (1900 G/cm)
    • Maximum MR system reported, whole-body averaged specific absorption rate (SAR) of 2.0 W/kg (normal operating mode)

    Under the scan conditions defined above, the device is expected to produce a maximum temperature rise of less than or equal to 4°C after 15 minutes of continuous scanning.

    In non-clinical testing, the image artifact caused by the device extends radially up to 20 mm from the device when imaged with a gradient echo pulse sequence in a 3.0T MR system.

    POTENTIAL ADVERSE EVENTS

    Potential adverse events associated with the device or implant procedure include, but are not limited to, the following:

    • Air embolism
    • Airway trauma
    • Allergic reaction
    • Anemia
    • Anesthesia reaction (nausea, vasovagal reaction, confusion/altered mental status or other)
    • Arrhythmia
    • Atrial septal defect
    • Bleeding
    • Cardiac arrest
    • Cardiac tamponade
    • Chest pain/discomfort
    • Congestive heart failure
    • Death
    • Device embolization
    • Device erosion
    • Device malfunction
    • Device malposition
    • Device migration
    • Device-related thrombus
    • Fever
    • Hematuria
    • Hypertension/hypotension
    • Infection
    • Multi-organ failure
    • Myocardial infarction
    • Perforation
    • Pericardial effusion
    • Pleural effusion
    • Renal failure/dysfunction
    • Respiratory failure
    • Seizure
    • Significant residual flow
    • Stroke
    • Thrombocytopenia
    • Thromboembolism: peripheral and pulmonary
    • Thrombus formation 
    • Transient ischemic attack 
    • Valvular regurgitation/insufficiency
    • Vascular access site injury (hematoma, pseudoaneurysm, arteriovenous fistula, groin pain or other)
    • Vessel trauma/injury

  • AMPLATZER™ TALISMAN™ PFO OCCLUDER
    INDICATION FOR USE


    The Amplatzer™ Talisman™ PFO Occluder is indicated for percutaneous transcatheter closure of a patent foramen ovale (PFO) to reduce the risk of recurrent ischemic stroke in patients, predominantly between the ages of 18 and 60 years, who have had a stroke due to a presumed paradoxical embolism, as determined by a neurologist and cardiologist following an evaluation to exclude other causes of ischemic stroke.

    CONTRAINDICATIONS

    • Presence of thrombus at the intended site of implant, or documented evidence of venous thrombus in the vessels through which access to the defect is gained.
    • Patients with intra-cardiac thrombus, mass, vegetation, or tumor.
    • Patients whose vasculature, through which access to the PFO is gained, is inadequate to accommodate the appropriate sheath size.
    • Patients with anatomy in which the required Amplatzer™ Talisman™ PFO device size would interfere with other intracardiac or intravascular structures, such as valves or pulmonary veins.
    • Patients with another source of right-to-lehunts, including an atrial septal defect and/or fenestrated septum.
    • Patients with active endocarditis or other untreated infections.
    • Patients who are unable to tolerate intra-procedural anticoagulation or post-procedural anti-platelet therapy.

    WARNINGS

    • Do not use an open or damaged pouch; do not use a damaged device.
    • Patients who are at increased risk for venous thromboembolic events should be managed with thromboembolic risk reduction regimen after the PFO closure following standard of care.
    • The safety and effectiveness of the Amplatzer™ Talisman™ PFO Occluder has not been established in patients with a hypercoagulable state.
    • Prepare for situations that require percutaneous or surgical removal of this device. This includes availability of a surgeon and access to operating room.
    • Embolized devices must be removed as they may disrupt critical cardiac functions. Do not remove an embolized occluder through intracardiac structures unless the occluder is fully recaptured inside a catheter or sheath.
    • The Amplatzer™ Talisman™ PFO Occluder device consists of a nickel-titanium alloy, which is generally considered safe. However, in vitro testing has demonstrated that nickel is released from this device for a minimum of 60 days. Patients who are allergic to nickel may have an allergic reaction to this device, especially those with a history of metal allergies. Certain allergic reactions can be serious; patients should be instructed to notify their physicians immediately if they suspect they are experiencing an allergic reaction such as difficulty breathing or inflammation of the face or throat. Some patients may also develop an allergy to nickel if this device is implanted.
    • Transient hemodynamic compromise may be encountered during device placement, which may require fluid replacement or other medications as determined by the physician.
    • Prior to device detachment, evaluate the position of the device relative to the free atrial wall and the aortic root using echocardiography.
    • Use echocardiography to ensure that the device does not impinge on the free atrial wall or aortic root.
    • Do not release the device from the delivery cable if the device does not conform to its original configuration, or if the device position is unstable or if the device interferes with any adjacent cardiac structure (such as Superior Vena Cava (SVC), Pulmonary Vein (PV), Mitral Valve (MV), Coronary Sinus (CS), aorta (AO)). If the device interferes with an adjacent cardiac structure, recapture the device and redeploy. If still unsatisfactory, recapture the device and either replace with a new device or consider alternative treatments.
    • DO NOT use the Amplatzer™ Talisman™ PFO Occluder after the Use-by date stated on the package label.
    • This device was sterilized with ethylene oxide and is for single use only. Never reuse or re-sterilize the system. Use of expired, reused, or re-sterilized devices may result in infection.
    • This device should be used only by physicians who are trained in standard transcatheter techniques.

    PRECAUTIONS FOR SPECIAL POPULATIONS

    • Pregnancy: The safety and effectiveness of this occluder has not been established during pregnancy. Fluoroscopic x-ray guidance is used during placement of the device. The risk of increased X-ray exposure for patients who are pregnant must be weighed against the potential benefits of this technique.
    • Nursing mother: The safety and effectiveness of this occluder has not been established in lactating mothers. There has been no quantitative assessment for the presence of leachables in breast milk.
    • Pediatric Population: The safety and effectiveness of this occluder has not been established in a pediatric population.

    PRECAUTIONS

    • Aspirin(325mg/day)(oralternativeantiplatelet/anticoagulant,if patient has aspirin intolerance) is recommended to be started at least 24 hours prior to the procedure.
    • Antibiotics should be administered peri-procedurally.
    • Patients should be fully heparinized throughout the procedure using adequate dosing so as to keep the activated clotting time (ACT) greater than 200 seconds.

    CAUTION: Intracardiac echocardiography (ICE) or transesophageal echocardiography (TEE) is recommended as an aid in evaluating the PFO and placing the AmplatzerTM TalismanTM PFO Occluder. If TEE is used, the patient’s esophageal anatomy must be adequate for placement.

    CAUTION: Be cautious when using fluoroscopic X-ray guidance, which may be used during placement of the device.

    CAUTION: Do not use a power injection system to put contrast solution through the sheath.

    • The safety and effectiveness of the AmplatzerTM TalismanTM PFO Occluder has not been established in patients (with):
      • Age less than 18 years or greater than 60 years because enrollment in the pivotal study (the RESPECT trial) was limited to patients 18 to 60 years old
      • A hypercoagulable state including those with a positive test for a anticardiolipin antibody (IgG or IgM), Lupus anticoagulant, beta-2 glycoprotein-1 antibodies, or persistently elevated fasting plasma homocysteine despite medical therapy
      • Unable to take antiplatelet therapy
      • Atherosclerosis or other arteriopathy of the intracranial and extracranial vessels associated with a ≥50% luminal stenosis
      • Acute or recent (within 6 months) myocardial infarction or unstable angina
      • Left ventricular aneurysm or akinesis
      • Mitral valve stenosis or severe mitral regurgitation, irrespective of etiology
      • Aortic valve stenosis (mean gradient greater than 40 mmHg) or severe aortic valve regurgitation
      • Mitral or aortic valve vegetation or prosthesis
      • Aortic arch plaques protruding greater than 4 mm into the aortic lumen
      • Left ventricular dilated cardiomyopathy with left ventricular ejection fraction (LVEF) less than 35%
      • Chronic, persistent, or paroxysmal atrial fibrillation or atrial flutter
      • Uncontrolled hypertension or uncontrolled diabetes mellitus
      • Diagnosis of lacunar infarct probably due to intrinsic small vessel as qualifying stroke event
      • Arterial dissection as cause of stroke
      • Index stroke of poor outcome (modified Rankin score greater than 3)
      • Pregnancy at the time of implant
      • Multi-organ failure

    PATIENT COUNSELING INFORMATION

    Physicians should review the following information when counseling patients about the AmplatzerTM TalismanTM PFO Occluder and the implant procedure:

    • The safety and effectiveness of PFO closure withthe AmplatzerTM TalismanTM PFO Occluder in combination with the required post- implant antiplatelet therapy.
    • PFO closure with the AmplatzerTM TalismanTM PFO Occluder can only reduce the risk for a recurrent stroke due to a paradoxical embolism through a PFO.
      • With aging, there is an increased likelihood that non-PFO related risks for stroke may develop and cause a recurrent ischemic stroke independent of PFO closure.
    • The procedural risks associated with AmplatzerTM TalismanTM PFO Occluder.
    • The need for adherence to a defined adjunctive antithrombotic therapy following implantation of the AmplatzerTM TalismanTM PFO Occluder.
    • Patients with a history of DVT or PE may benefit from continuation or resumption of anticoagulation therapy following implantation of the AmplatzerTM TalismanTM PFO Occluder to reduce the risk of recurrent DVT or PE.

    It is recommended that the medical team (neurologist and cardiologist) and the patient engage in a shared decision-making process and discuss the risks and benefits of PFO closure in comparison to using antithrombotic therapy alone, while taking into account the patient’s values and preferences.

    POTENTIAL ADVERSE EVENTS

    Potential adverse events that may occur during or after a procedure using this device may include, but are not limited to:

    • Air embolus
    • Allergic reaction/toxic effect due to: anesthesia, contrast media, medication, or metal
    • Arrhythmia
    • Arteriovenous fistulae
    • Bleeding
    • Cardiac perforation
    • Cardiac tamponade
    • Chest pain
    • Death
    • Deep vein thrombosis
    • Device embolization
    • Device erosion
    • Endocarditis
    • Esophagus injury
    • Fever
    • Headache/migraine
    • Hematoma
    • Hypertension/hypotension
    • Infection
    • Myocardial infarction
    • Pacemaker placement secondary to PFO device closure
    • Pain
    • Pericardial effusion
    • Pericarditis
    • Peripheral embolism
    • Pseudoaneurysm
    • Pulmonary embolism
    • Reintervention for residual shunt/device removal
    • Stroke
    • Transient ischemic attack
    • Thrombus formation
    • Valvular regurgitation
    • Vascular access site injury
    • Vessel perforation

  • AMPLATZER™ MULTI-FENESTRATED SEPTAL OCCLUDER – CRIBRIFORM
    INDICATIONS FOR USE


    The AMPLATZER™ Cribriform Occluder is a percutaneous, transcatheter, atrial septal defect closure device intended for the closure of multifenestrated (cribriform) atrial septal defects (ASD). Patients indicated for ASD closure have echocardiographic evidence of fenestrated ostium secundum atrial septal defect and clinical evidence of right ventricular volume overload (such as, 1.5:1 degree of left-to-right shunt or right ventricular enlargement).

    CONTRAINDICATIONS

    The AMPLATZER™ Cribriform Occluder is contraindicated for the following:

    • Treatment of patients with patent foramen ovale (PFO) defects. This device has not been studied in patients with PFO defects.
    • Patients known to have extensive congenital cardiac anomaly, which can only be adequately repaired by way of cardiac surgery.
    • Patients known to have sepsis within 1 month prior to implantation, or any systemic infection that cannot be successfully treated prior to device placement.
    • Patients known to have a bleeding disorder, untreated ulcer, or any other contraindications to aspirin therapy unless another anti-platelet agent can be administered for 6 months.
    • Patients known to have demonstrated intracardiac thrombi on echocardiography (especially left atrial or left atrial appendage thrombi).
    • Patients whose size (such as, too small for transesophageal echocardiography (TEE) probe, catheter size, vasculature size) or condition (active infection, etc.) would cause the patient to be a poor candidate for cardiac catheterization.
    • Any patient where the radius of the device is greater than the distance from the central defect to the aortic root or superior vena cava.

    WARNINGS

    • Physicians must be prepared to deal with urgent situations, such as device embolization, which require removal of the device. This includes the availability of an on-site surgeon.
    • Embolized devices must be removed as they may disrupt critical cardiac functions. Embolized devices should not be withdrawn through intracardiac structures unless they have been adequately collapsed within the sheath.
    • Use on or before the last day of the expiration month noted on the product packaging.
    • This device is sterilized using ethylene oxide and is for single use only. Do not reuse or resterilize. Attempts to resterilize the device may result in device malfunction, inadequate sterilization, or patient harm.
    • Do not use the device if the packaging sterile barrier is open or damaged.
    • Do not release the AMPLATZER™ Cribriform Occluder from the delivery cable if the device does not conform to its original configuration or if the device position is unstable. Recapture the device and redeploy. If still unsatisfactory, recapture the device and replace with a new device.
    • Implantation of this device may not supplant the need for Coumadin in patients with ASD and paradoxical emboli.
    • The use of transthoracic, transesophageal, or intracardiac echocardiographic imaging (TTE, TEE, or ICE) is required.

    PRECAUTIONS

    • The use of this device has not been studied in patients with patent foramen ovale.
    • Use standard interventional cardiac catheterization techniques to place this device.
    • This device contains nickel-titanium alloy, which is generally considered safe. However, in vitro testing has demonstrated that nickel is released from this device for a minimum of 60 days. Patients who are allergic to nickel may have an allergic reaction to this device, especially those with a history of metal allergies. Certain allergic reactions can be serious; patients should be instructed to seek medical assistance immediately if they suspect they are experiencing an allergic reaction. Symptoms may include difficulty in breathing or swelling of the face or throat. While data is currently limited, it is possible that some patients may develop an allergy to nickel if this device is implanted.

    Handling

    • Store in a dry place.

    Patient Selection

    • Certain patients may be at higher risk for complications such as tissue erosion and device embolization. If higher risk patients have devices implanted, closer follow-up is warranted (see “Post-procedure Instructions” on page 9). Higher risk patients include the following:
      • Patients with deformation of the device at the aortic root
      • Patients with high defects (minimal aortic and superior rims)
      • Patients with less than a 9-mm distance from the central defect to the aortic root or superior vena cava orifice

    Procedural

    • This device should only be used by physicians who have been trained in transcatheter techniques and who should determine which patients are suitable candidates for procedures using this device.
    • The physician should exercise clinical judgment in situations that involve the use of anticoagulants or antiplatelet drugs before, during, and/or after the use of this device.
    • Aspirin (for example, 81 mg or 325 mg) or an alternative antiplatelet/anticoagulant is recommended to be started at least 24 hours prior to the procedure.
    • Maintain a recommended minimum active clotting time (ACT) of 200 seconds prior to device insertion and throughout the procedure.
    • If TEE is used, the patient’s esophageal anatomy must be adequate for placement and manipulation of the TEE probe.

    Post-implant

    • Patients should take appropriate endocarditis prophylaxis for 6 months following device implantation. The decision to continue endocarditis prophylaxis beyond 6 months is at the discretion of the physician.
    • Patients should be treated with antiplatelet/ anticoagulation therapy (such as aspirin) for 6 months post-implant. The decision to continue antiplatelet/ anticoagulation therapy beyond 6 months is at the discretion of the physician.

    Use in Specific Populations

    • Pregnancy — Care should be taken to minimize the radiation exposure to the fetus and the mother.
    • Nursing mothers — There has been no quantitative assessment of the presence of leachables from the device/procedure in breast milk, and the risk to nursing mothers is unknown.

    MR Conditional

    Through nonclinical testing, the AMPLATZER™ Septal Occluder has been shown to be MR Conditional at field strengths of 3.0 tesla or less with a maximum whole-body-averaged specific absorption rate (SAR) of 3.83 W/ kg at 1.5 tesla and 5.57 W/kg at 5.O tesla for a 20-minute exposure to a Bl of 118 μT. The AMPLATZER™ Septal Occluder should not migrate in this MR environment. The nonclinical testing has not been performed to rule out the possibility of migration at field strengths higher than 3.0 tesla.
    In this testing, the device produced a temperature rise of 1.1°C at 1.5 tesla and 1.6°C at 5.0 tesla.
    MR image may be compromised if the area of interest is in the exact same area or relatively close to the position of the device.

    ADVERSE EVENTS

    Observed Adverse Events — Tissue Erosion/Perforation

    The reported incidence of tissue erosion/perforation is approximately 1 in 1,000 patients treated with the AMPLATZER™ Septal Occluder. Tissue erosion, while rare, has led to cardiac tamponade and death. Tissue erosion/perforation refers to the erosion or abrasion of the tissue of the atrium primarily in the area of the roof of the atrium near the aorta.

    Potential Adverse Events

    Potential adverse events may occur during or after a procedure placing this device may include, but are not limited to:
    Air embolus; Allergic dye reaction; Anesthesia reactions; Apnea; Arrhythmia; Brachial plexus injury; Cardiac perforation; Death; Device collapse due to structural failure; Device embolization; Device removal (due to embolization or misplacement); Erosion; Fever; Headache/migraines; Hematoma/pseudoaneurysm including blood loss requiring transfusion; Hypertension; Hypotension; Infection including endocarditis; Infectious endocarditis; Pericardial effusion; Perforation of vessel or myocardium; Phrenic nerve injury; Stroke/ transient ischemic attack; Thrombus formation on the device surface with the risk of subsequent embolization; Valvular regurgitation; Vascular access site complications

  • AMPLATZER™ MUSCULAR VSD OCCLUDER
    INDICATION AND USAGE


    The AMPLATZER™ Muscular VSD Occluder is indicated for use in patients with a complex ventricular septal defect (VSD) of significant size to warrant closure (large volume left-to-right shunt, pulmonary hypertension, and/or clinical symptoms of congestive heart failure) who are considered to be at high risk for standard transatrial or transarterial surgical closure based on anatomical conditions and/or based on overall medical condition. High-risk anatomical factors for transatrial or transarterial surgical closure include patients:

    • Requiring left ventriculotomy or an extensive right ventriculotomy.
    • With a failed previous VSD closure.
    • With multiple apical and/or anterior muscular VSDs (“Swiss cheese septum”).
    • With posterior apical VSDs covered by trabeculae.

    CONTRAINDICATIONS

    The AMPLATZER™ Muscular VSD Occluder is contraindicated for the following:

    • Patients with defects less than 4 mm distance from the semilunar (aortic and pulmonary) and atrioventricular valves (mitral and tricuspid)
    • Patients with severely increased pulmonary vascular resistance above 7 Wood units and a right-to-left shunt and documented irreversible pulmonary vascular disease
    • Patients with perimembranous (close to the aortic valve) VSD
    • Patients with post-infarction VSD
    • Patients who weigh less than 5.2 kg. (Patients smaller than 5.2 kg were studied in the clinical trial, but due to poor outcome, these patients have been contraindicated for device placement. Data from these patients has not been included in the overall analysis.)
    • Patients with sepsis (local/generalized)
    • Patients with active bacterial infections
    • Patients with contraindications to antiplatelet therapy or agents

    WARNINGS

    • The AMPLATZER™ Muscular VSD Occluder and delivery system should only be used by those physicians trained in transcatheter defect closure techniques.
    • Physicians must be prepared to deal with urgent situations, such as device embolization, which require removal of the device. This includes the availability of an on-site surgeon. 
    • Embolized devices must be removed. Embolized devices should not be withdrawn through intracardiac structures unless they have been adequately collapsed within a sheath.
    • Use on or before the last day of the expiration month noted on the product packaging.
    • The device is sterilized using ethylene oxide and is for single use only. Do not reuse or resterilize. Attempts to resterilize the device may result in device malfunction, inadequate sterilization, or patient harm.
    • Do not use the device if the packaging sterile barrier is open or damaged.
    • Do not release the AMPLATZER™ Muscular VSD Occluder from the delivery cable if the device does not conform to its original configuration or if the device position is unstable. Recapture the device and redeploy. If still unsatisfactory, recapture the device and replace with a new device.
    • Device closure in patients who have suffered a previous thromboembolic stroke should be discussed with the patient or family. In addition, consultation with a neurologist and hematologist is suggested to determine if the benefit of device closure outweighs the risk.

    PRECAUTIONS

    Handling
    Store in a dry place.

    Sizing
    Accurate defect sizing is crucial and mandatory for AMPLATZER™ Muscular VSD Occluder device selection. The VSD should be assessed and sized at end diastole by transesophogeal echocardiography (TEE) or angiography to determine the appropriate device size. Device selection should be 2 mm larger than the defect size.

    Procedural

    • This device contains nickel-titanium alloy, which is generally considered safe. However, in vitro testing has demonstrated that nickel is released from this device for a minimum of 60 days. Patients who are allergic to nickel may have an allergic reaction to this device, especially those with a history of metal allergies. Certain allergic reactions can be serious; patients should be instructed to seek medical assistance immediately if they suspect they are experiencing an allergic reaction. Symptoms may include difficulty in breathing or swelling of the face or throat. While data is currently limited, it is possible that some patients may develop an allergy to nickel if this device is implanted.
    • The physician should exercise clinical judgment in situations that involve the use of anticoagulants or antiplatelet drugs before, during, and/or after the use of this device.
    • This device should only be used by physicians who have been trained in transcatheter techniques and who should determine which patients are suitable candidates for procedures using this device.
    • Aspirin (eg, 81 mg or 325 mg) or an alternative antiplatelet/anticoagulant is recommended to be started at least 24 hours prior to the procedure. Cephalosporin therapy is optional. 
    • Maintain a recommended minimum active clotting time (ACT) of 200 seconds prior to device insertion and throughout the procedure.
    • If TEE is used, the patient’s esophogeal anatomy must be adequate for placement and manipulation of the TEE probe.
    • Patients requiring multiple devices and/or concomitant catheterization procedures might require prolonged fluoroscopy times and multiple cineangiograms. The risks of radiation exposure (eg, increased cancer risk) should be discussed in detail with the patient or family and alternatives which do not involve radiation exposure should be reviewed.

    Post-implant

    • Patients should be treated with antiplatelet/anticoagulation therapy (such as aspirin) for 6 months post-implant. The decision to continue antiplatelet/anticoagulation therapy beyond 6 months is at the discretion of the physician.
    • Endocarditis prophylaxis should be followed according to the American Heart Association recommendations.
    • Any patient who has a residual shunt should undergo an echocardiographic evaluation of the residual shunt every 6 months until complete closure of the defect has been confirmed.
    • Patients should be instructed to avoid strenuous activity for 1 month. Strenuous activities such as contact sports prior to 1 month after implant may cause the device to dislodge and embolize.

    Use in Specific Populations

    • Pregnancy - Care should be taken to minimize the radiation exposure to the fetus and the mother.
    • Nursing mothers - There has been no quantitative assessment of the presence of leachables from the device/procedure in breast milk, and the risk to nursing mothers is unknown.

    MR Conditional1
    Through non-clinical testing, AMPLATZER™ devices have been shown to be MR Conditional. A patient with an implanted AMPLATZER™ device can be scanned safely immediately after placement of the device under the following conditions:

    • Static magnetic field of 3 tesla or less
    • Spatial gradient magnetic field of 720 G/cm or less
    • Maximum MR system-reported, whole-body-averaged specific absorption rate (SAR) of 3 W/kg for 15 minutes of scanning

    During testing, the device produced a clinically non-significant temperature rise at a maximum MR system-reported, whole-body-averaged specific absorption rate (SAR) of 3 W/kg for 15 minutes of scanning in a 3 tesla MR system using a transmit/receive body coil.

    MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the device. Therefore, optimization of MR imaging parameters to compensate for the presence of this device may be necessary.

    POTENTIAL ADVERSE EVENTS

    Potential adverse events may occur during or after a procedure using this device may include, but are not limited to:

    Air embolus; Allergic drug reaction; Allergic dye reaction; Anemia; Anesthesia reactions; Apnea; Arrhythmia; Arterial pulse loss; Atelectasis; Bacterial endocarditis; Blood loss requiring transfusion; Brachial plexus injury; Cardiac arrest; Cardiomyopathy; Chest pain; Cyanosis; Death; Device embolization; Device fracture; Fever; Headache/migraine; Heart block; Hypotension; Myocardial infarction; Perforation of the vessel or myocardium; Peripheral embolism; Stridor; Stroke; Subaortic stenosis; Thrombus formation on device; Vascular access site injury; Venous thrombosis; Vomiting

    1. MR Conditional as defined in ASTM F 2503-05.

  • AMPLATZER PICCOLOTM OCCLUDER
    INDICATIONS AND USAGE

    The AMPLATZER PiccoloTM Occluder is a percutaneous, transcatheter occlusion device intended for the nonsurgical closure of a patent ductus arteriosus (PDA).

    CONTRAINDICATIONS

    • Weight < 700 grams at time of the procedure
    • Age < 3 days at time of procedure
    • Coarctation of the aorta
    • Left pulmonary artery stenosis
    • Cardiac output that is dependent on right to left shunt through the PDA due to pulmonary hypertension
    • Intracardiac thrombus that may interfere with the implant procedure
    • Active infection requiring treatment at the time of implant
    • Patients with a PDA length smaller than 3 mm
    • Patients with a PDA diameter that is greater than 4 mm at the narrowest portion

    WARNINGS

    • This device was sterilized with ethylene oxide and is for single use only. Do not reuse or re-sterilize this device. Attempts to resterilize this device can cause a malfunction, insufficient sterilization, or harm to the patient.
    • Do not use the device if the sterile package is open or damaged.
    • Use on or before the last day of the expiration month that is printed on the product packaging label.
    • Patients who are allergic to nickel can have an allergic reaction to this device.
    • Prepare for situations that require the removal of this device. Preparation includes access to a transcatheter snare kit and an on-site surgeon.
    • Accurate measurements of the ductus are crucial for correct occluder size selection.
    • Do not release the occluder from the delivery wire if either a retention disc protrudes into the pulmonary artery or aorta; or if the position of the occluder is not stable.
    • Remove embolized devices. Do not remove an embolized occluder through intracardiac structures unless the occluder is fully recaptured inside a catheter.

    PRECAUTIONS

    • This device should be used only by physicians who are trained in standard transcatheter techniques. Determine which patients are candidates for procedures that use this device.
    • The physician should exercise clinical judgment in situations that involve the use of anticoagulants and antiplatelet drugs before, during, and/or after the use of this device.
    • Patients should have an activated clotting time (ACT) of greater than 200 sec prior to device placement, unless the patient has a significant risk for bleeding and is unable to be anti-coagulated.
    • The device may be delivered via an anterograde (venous) or a retrograde (arterial) approach. However, in small infants (≤2 kg), the device should be delivered using the anterograde (venous) approach since small infants are at an increased risk for arterial injury.
    •  The AMPLATZER PiccoloTM Occluder contains nickel-titanium alloy, which is generally considered safe. However, in vitro testing has demonstrated that nickel is released from this device for a minimum of 60 days following implant. Patients who are allergic to nickel may have an allergic reaction to this device, especially those with a history of metal allergies. Certain allergic reactions can be serious; patients should seek immediate medical attention if there is suspicion of an allergic reaction. Symptoms may include difficulty in breathing or swelling of the face or throat. While data are currently limited, it is possible that some patients may develop an allergy to nickel if this device is implanted.
    • Use in specific populations
      • Pregnancy — Minimize radiation exposure to the fetus and the mother.
      • Nursing mothers — There has been no quantitative assessment for the presence of leachables in breast milk.
    • Store in a dry place.
    • Do not use contrast power injection with delivery catheter.

    MR CONDITIONAL

    St. Jude Medical’s AMPLATZERTM Duct Occluder II device is manufactured of chemically etched nitinol wire, 80% platinum 20% iridium marker band and a 316L end screw.

    Non-clinical testing has demonstrated that the AMPLATZERTM Duct Occluder II device is MR-Conditional. Patients can be scanned safely immediately after implantation under the following conditions:

    • Static magnetic field of 1.5 Tesla (1.5T) or 3.0 Tesla (3.0T).
    • Maximum spatial gradient field less than or equal to 30 T/m.
    • Maximum whole-body-averaged specific absorption rate (SAR) of 2.0 W/kg (normal operating mode) for 15 minutes of scanning.

    In non-clinical testing with body coil excitation, the AMPLATZERTM Duct Occluder II device produced a differential temperature rise of less than or equal to 3.65°C when exposed to a maximum average whole body specific absorption rate (SAR) of 2.80 W/kg for 15 minutes of scanning in a 1.5 Tesla MR system (SiemensTM MAGNETOM EspreeTM, SYNGOTM MR B17 software, Erlangen, Germany). Scaling of the SAR and observed heating indicates that average whole body SAR of 2.0 W/kg would be expected to yield a localized temperature rise of less than or equal to approximately 1.0°C in Normal Operating Mode.

    MR Image quality may be compromised if the area of interest is the same or relatively close to the position of the device. Therefore, it may be necessary to optimize the MR imaging parameters for the presence of this implant.

    POTENTIAL ADVERSE EVENTS

    Potential adverse events that may occur during or after a procedure placing this device include, but are not limited to:

    • Air embolus
    • Allergic dye reaction
    • Allergic drug reaction
    • Anesthesia reactions
    • Apnea
    • Arrhythmia
    • Bacterial endocarditis
    • Bleeding
    • Cardiac perforation
    • Cardiac tamponade
    • Chest pain
    • Device embolization
    • Device erosion
    • Death
    • Fever
    • Headache/migraine
    • Hemolysis
    • Hematoma
    • Hypertension
    • Hypotension
    • Infection
    • Myocardial infarction
    • Palpitations
    • Partial obstruction of aorta
    • Partial obstruction of pulmonary artery
    • Pericardial effusion
    • Pericarditis
    • Peripheral embolism
    • Pleural effusion
    • Pulmonary embolism
    • Re-intervention for device removal
    • Respiratory distress
    • Stroke
    • Thrombus
    • Transient ischemic attack
    • Valvular regurgitation
    • Vascular access site injury
    • Vascular occlusion
    • Vessel perforation

  • AMPLATZERTM DUCT OCCLUDER AND DELIVERY SYSTEM
    INDICATIONS AND USAGE


    The AMPLATZERTM Duct Occluder is a percutaneous, transcatheter occlusion device intended for the nonsurgical closure of a patent ductus arteriosus (PDA).

    CONTRAINDICATIONS

    • Patients weighing less than 6 kg
    • Patients less than 6 months of age
    • Presence of thrombus at the intended site of implant, or documented evidence of venous thrombus in the vessels through which access to the defect is gained
    • Active endocarditis or other infections producing bacteremia
    • Patients whose vasculature, through which access to the defect is gained, is inadequate to accommodate the appropriate sheath size
    • Patients with pulmonary hypertension with pulmonary vascular resistance of greater than 8 Wood units or Rp/Rs of greater than 0.4

    WARNINGS

    • The device should be removed if greater than 3 mm extends into the pulmonary artery, or if more than half of the left pulmonary artery lumen is occupied by the device.
    • There is limited clinical data for patients over 40 years of age.
    • The AMPLATZERTM Duct Occluder and 180° Delivery System should only be used by those physicians trained in transcatheter defect closure techniques.
    • Physicians must be prepared to deal with urgent situations which require removal of embolized devices that result in critical hemodynamic compromise. This includes the availability of an on-site surgeon. 
    • Embolized devices must be removed. Embolized devices should not be withdrawn through intracardiac structures unless they have been adequately collapsed within a sheath.
    • Do not use if the sterile barrier has been compromised in any way.
    • Do not release the AMPLATZERTM Duct Occluder from the delivery cable if the device does not conform to its original configuration or if the device position is unstable. Recapture the device and redeploy. If still unsatisfactory, recapture the device and replace with a new device.

    PRECAUTIONS

    Handling
    The AMPLATZERTM Duct Occluder and 180° Delivery System were sterilized with ethylene oxide and are for single use only. Do not reuse or resterilize. Attempts to resterilize this device can cause a malfunction,  insufficient sterilization, or harm to the patient.

    Sizing
    Accurate defect sizing is crucial and mandatory for AMPLATZER™ Duct Occluder device selection. Refer to Table 4 for sizing instructions.

    Procedural

    • This device contains nickel-titanium alloy, which is generally considered safe. However, in vitro testing has demonstrated that nickel is released from this device for a minimum of 60 days. Patients who are allergic to nickel may have an allergic reaction to this device, especially those with a history of metal allergies. Certain allergic reactions can be serious; patients should be instructed to seek medical assistance immediately if they suspect they are experiencing an allergic reaction. Symptoms may include difficulty in breathing or swelling of the face or throat. While data is currently limited, it is possible that some patients may develop an allergy to nickel if this device is implanted. Some forms of nickel have also been associated with carcinogenicity (ability to cause cancer) in animal models. In humans, carcinogenicity has been demonstrated only through an inhalation route (breathing nickel in) which will not occur with this procedure.
    • The physician should exercise clinical judgment in situations that involve the use of anticoagulants or antiplatelet drugs before, during, and/or after the use of this device.

    Post-implant

    • Endocarditis prophylaxis is carried out for 6 months according to the recommendation of the American Heart Association. The decision to continue endocarditis prophylaxis beyond 6 months is at the discretion of the physician.
    • Any patient who has a residual shunt will undergo an echo cardiographic evaluation of the residual shunt until complete closure of the defect has been confirmed.
    • Lung perfusion scan should be completed if flow through is greater than 3 m/s, or if the Z-score is -2 for the left pulmonary artery diameter.
    • MR Conditional to 3.0 Tesla
      Through nonclinical testing, the AMPLATZERTM device has been known to be MR Conditional at field strengths of 3.0 tesla or less with a maximum whole-body-averaged specific absorption rate (SAR) of 3.83 W/kg at 1.5 tesla and 5.57 W/kg at 5.0 tesla for a 20-minute exposure to a B1 of 118μ tesla. The AMPLATZERTM device should not migrate in this MR environment. Nonclinical testing has not been performed to rule out the possibility of migration at field strengths higher than 3.0 tesla.
      In this testing, the device produced a temperature rise of 1.1°C at 1.5 tesla and 1.6°C at 5.0 tesla.
      MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the device.

    Use in Specific Populations

    • Pregnancy — Care should be taken to minimize the radiation exposure to the fetus and the mother.
    • Nursing mothers — There has been no quantitative assessment of the presence of leachables in breast milk.

    POTENTIAL ADVERSE EVENTS

    Placement of the AMPLATZERTM Duct Occluder involves using standard interventional cardiac catheterization techniques. In addition to the above observed adverse events, the following are potential adverse events listed in alphabetical order that were not observed in the clinical study.

    The following events might occur from either the catheterization procedure or from the device:

    • Air embolus
    • Allergic drug reaction
    • Allergic dye reaction
    • Anesthesia reactions
    • Apnea
    • Arrhythmia
    • Bacterial endocarditis
    • Bleeding
    • Brachial plexus injury
    • Chest pain
    • Death
    • Delivery system failure
    • Fever
    • Headache/migraine
    • Hypertension/hypotension
    • Myocardial infarction
    • Partial obstruction of aorta
    • Partial obstruction of pulmonary artery
    • Perforation of vessel or myocardium
    • Peripheral embolism
    • Stroke/transient ischemic attack
    • Thrombus
    • Valvular regurgitation
    • Vascular access site complications
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