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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 STRUCTURAL HEART PRODUCTS

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

Transcatheter Valve Solutions

  • MITRACLIP™ FOR TEER

    Cardiovascular Physiology in Mitral Regurgitation

    Read more
  • Hemodynamic Monitoring during MitraClip™ Procedures
    MITRACLIP™ FOR TEER

    Hemodynamic Monitoring During MitraClip™ Procedures

    Read more

TAVI

  • PORTICO™ FOR TAVI

    Portico™ Valve Meets Non-Inferiority Criteria for Safety and Efficacy in Two-Year Analysis1

    Read more

Structural Interventions

  • AMPLATZER™ AMULET™ LAA OCCLUDER

    Clinical Experience with Amplatzer™ Amulet™ Left Atrial Appendage Occluder for Reducing Risk of Ischemic Stroke in Patients with AF.

    Read more
  • 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

Surgical Valve Solutions

  • MASTERS SERIES AND REGENT AORTIC MECHANICAL HEART VALVES

    Bileaflet Aortic Mechanical Heart Valves, Low INR Management For Low Risk Patients: A Class Effect?

    Read more
  • MASTERS SERIES MITRAL MECHANICAL HEART VALVES

    Key Mitral MHV Selection Considerations: Durability,
    Size Range, Hemodynamics, and Implantability1

    Read more
  • EPIC™ MITRAL STENTED TISSUE VALVE WITH LINX™ AC TECHNOLOGY

    Epic Mitral – Ten Year Clinical Outcomes of SMVR in a Medicare Population1

    Read more
  • 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 Years2

    Read more
  • EPIC™ MITRAL AND EPIC™ SUPRA STENTED TISSUE VALVES

    Three-Year Outcomes of Valve-in-Valve Intervention within the Epic™ Supra and Epic™ Mitral Valves in a Medicare Population

    Read more
  • EPIC™ SUPRA AORTIC STENTED TISSUE VALVE WITH LINX™ AC TECHNOLOGY

    Ten-Year Outcomes of a Contemporary Supra-annular Porcine Aortic Bioprosthesis in a Medicare Population1

    Read more

CLINICAL DATA | STRUCTURAL INTERVENTIONS

MAT-2116292 v6.0 | Item approved for U.S. use only.

References

*Data on File at Abbott

  1. Rodriguez, E. et. al. (2022, January). Ten-Year Outcomes of a Contemporary Generation Low-Profile Porcine Mitral Bioprosthesis in a Medicare Population. Poster presented at the STS Annual Meeting, Virtual.
  2. 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
  • Navitor
  • Portico
  • 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 regime; 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

    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 effuse on, 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

  • NAVITOR™ TRANSCATHETER AORTIC VALVE IMPLANTATION SYSTEM


    INDICATIONS

    The Navitor™ Transcatheter Aortic Valve Implantation System is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be high or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality ≥ 8% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical comorbidities unmeasured by the STS risk calculator).

    CONTRAINDICATIONS  

    The valve is contraindicated for patients with inability to tolerate antiplatelet/anticoagulant therapy or nitinol alloy (nickel and titanium), or who have active infections, including endocarditis.

    POTENTIAL ADVERSE EVENTS  

    Adverse events potentially associated with the use of transcatheter bioprosthetic heart valves include but are not limited to: access site complications (e.g., pain, bleeding, infection, hematoma, pseudoaneurysm, etc.); acute coronary obstruction; acute myocardial infarction; allergic reaction to antiplatelet agents, contrast medium, or valve components; aortic rupture; ascending aorta trauma; atrio-ventricular node block; cardiac arrhythmias; conduction system injury; conversion to open surgical procedure; death; dissection; embolism; emergent balloon valvuloplasty; emergent percutaneous coronary intervention (PCI); emergent surgery (i.e., coronary artery bypass, heart valve replacement); endocarditis; explantation; heart failure; hemodynamic compromise; hemolysis; hemolytic anemia; hemorrhage; hypotension or hypertension; infection; myocardial ischemia; mitral valve insufficiency; multi-organ failure; non-structural dysfunction (i.e., entrapment by pannus, paravalvular leak, inappropriate sizing or positioning); pannus; pericardial effusion; perforation of the myocardium, ventricle, or a blood vessel; permanent disability; permanent pacemaker; regurgitation; renal insufficiency or renal failure; reoperation; respiratory failure; sepsis; stroke; structural deterioration (i.e., calcification, leaflet tear); thrombosis; tamponade; transfusion; valve embolization or migration; vessel dissection or spasm.

  • PORTICO™ TRANSCATHETER
    AORTIC VALVE IMPLANTATION SYSTEM

    INDICATIONS

    The Portico™ Transcatheter Aortic Valve Implantation System is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be high or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality ≥ 8% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical comorbidities unmeasured by the STS risk calculator).

    CONTRAINDICATIONS

    The valve is contraindicated for patients with inability to tolerate antiplatelet/anticoagulant therapy or nitinol alloy (nickel and titanium), or who have active infections, including endocarditis.

    POTENTIAL ADVERSE EVENTS

    Adverse events potentially associated with the use of transcatheter bioprosthetic heart valves include but are not limited to: access site complications (e.g., pain, bleeding, infection, hematoma, pseudoaneurysm, etc.); acute coronary obstruction; acute myocardial infarction; allergic reaction to antiplatelet agents, contrast medium, or valve components; aortic rupture; ascending aorta trauma; atrio-ventricular node block; cardiac arrhythmias; conduction system injury; conversion to open surgical procedure; death; dissection; embolism; emergent balloon valvuloplasty; emergent percutaneous coronary intervention (PCI); emergent surgery (i.e., coronary artery bypass, heart valve replacement); endocarditis; explantation; heart failure; hemodynamic compromise; hemolysis; hemolytic anemia; hemorrhage; hypotension or hypertension; infection; myocardial ischemia; mitral valve insufficiency; multi-organ failure; non-structural dysfunction (i.e., entrapment by pannus, paravalvular leak, inappropriate sizing or positioning); pannus; pericardial effusion; perforation of the myocardium, ventricle, or a blood vessel; permanent disability; permanent pacemaker; regurgitation; renal insufficiency or renal failure; reoperation; respiratory failure; sepsis; stroke; structural deterioration (i.e., calcification, leaflet tear); thrombosis; tamponade; transfusion; valve embolization or migration; vessel dissection or spasm.

  • 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.

    Potential Adverse Events

    Adverse events potentially associated with the use of bioprosthetic 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.

     

  • 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.

    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.

    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™ SEPTAL OCCLUDER AND DELIVERY SYSTEM
    INDICATION FOR USE


    The AMPLATZER™ Septal Occluder is a percutaneous, transcatheter, atrial septal defect closure device intended for the occlusion of atrial septal defects (ASD) in secundum position or patients who have undergone a fenestrated Fontan procedure and who now require closure of the fenestration. Patients indicated for ASD closure have echocardiographic evidence of 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 RV enlargement).

    CONTRAINDICATIONS

    The AMPLATZER™ Septal Occluder is contraindicated for the following: Any patient known to have extensive congenital cardiac anomaly which can only be adequately repaired by way of cardiac surgery; Any patient known to have sepsis within 1 month prior to implantation, or any systemic infection that cannot be successfully treated prior to device placement; Any patient known to have a bleeding disorder, untreated ulcer, or any other contraindications to aspirin therapy, unless another antiplatelet agent can be administered for 6 months; Any patient known to have a demonstrated intracardiac thrombi on echocardiography (especially left atrial or left atrial appendage thrombi); Any patient whose size (such as, too small for transesophageal echocardiography probe, catheter size) or condition (active infection, etc.) would cause the patient to be a poor candidate for cardiac catheterization; Any patient where the margins of the defect are less than 5 mm to the coronary sinus, inferior vena cava rim, AV valves, or right upper lobe pulmonary vein.

    POTENTIAL COMPLICATIONS AND 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; Cardiac tamponade; Death; Embolization; Fever Hypertension/hypotension; Infection including endocarditis; Need for surgery; Pericardial effusion; Perforation of vessel or myocardium; Pseudoaneurysm including blood loss requiring transfusion; Stroke; Tissue erosion; Thrombus formation on discs; Valvular regurgitatio

  • 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

    POTENTIAL COMPLICATIONS AND ADVERSE EVENTS

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

    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

  • 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

    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, Anemia, Anesthesia reactions, Apnea, Arrhythmia, Bleeding, Cardiac perforation, Cardiac tamponade, Chest pain, Device embolization, Device erosion, Death, Endocarditis, 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

    Potential Complications and Adverse Events

    Placement of the AMPLATZER™ Duct Occluder involves using standard interventional cardiac catheterization techniques. 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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