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SURGICAL VALVE SOLUTIONS

The Abbott portfolio of surgical valves includes stented tissue valves, mechanical valves, and annuloplasty rings that are designed to rebuild healthier hearts.

SURGICAL VALVE SOLUTIONS

The Abbott portfolio of surgical valves includes stented tissue valves, mechanical valves, and annuloplasty rings that are designed to rebuild healthier hearts.

Epic Plus surgical replacement mitral and aortic valves

EPIC™ PLUS

SURGICAL REPLACEMENT
MITRAL & AORTIC VALVE

The latest generation of the Epic™ Platform continues the Epic product family’s history of excellence. The Epic Plus mitral and aortic valves feature Linx™ anticalcification technology* and provide the same trusted durability and performance—plus significant improvements to radiopacity and implantability to enable future interventions. The future-forward design gives you and your patients more choices when it comes to preserving long-term treatment paths.

Learn more about Epic Plus

*There is no clinical data currently available that evaluates the long-term impact of anticalcification tissue treatment in humans.

TRIFECTA™ GT

SURGICAL REPLACEMENT
AORTIC VALVE

The Trifecta™ valve with Glide™ Technology (GT) and Linx™ anticalcification technology* was designed to offer excellent performance in 3 key areas—hemodynamics, durability, and implantability—all of which are essential for optimal outcomes.

Learn more about Trifecta GT

*There is no clinical data currently available that evaluates the long-term impact of anticalcification tissue treatment in humans.

Trifecta GT surgical replacement aortic valve
Trifecta GT surgical replacement aortic valve

TRIFECTA™ GT

SURGICAL REPLACEMENT
AORTIC VALVE

The Trifecta™ valve with Glide™ Technology (GT) and Linx™ anticalcification technology* was designed to offer excellent performance in 3 key areas—hemodynamics, durability, and implantability—all of which are essential for optimal outcomes.

Learn more about Trifecta GT

*There is no clinical data currently available that evaluates the long-term impact of anticalcification tissue treatment in humans.

Regent surgical replacement mechanical aortic valve

REGENT™

SURGICAL REPLACEMENT
AORTIC VALVE

The Regent aortic mechanical heart valve delivers exceptional hemodynamics and clinical performance with a proven long-term legacy of structural integrity and durability. Abbott mechanical heart valves lead the way with a proven bileaflet design that results in low thrombogenicity and excellent patient outcomes.

Learn more about Regent

MASTERS SERIES

SURGICAL REPLACEMENT
AORTIC & MITRAL VALVE

The Masters Series aortic and mitral mechanical heart valves are rotatable, bileaflet valves designed for secure implantation. The portfolio includes an expansive range of sizes to help you make the best decisions for your patients. Unique design features have established Abbott mechanical heart valves as a gold standard for reliability and performance.

Learn more about Masters Series

Masters Series surgical replacement aortic and mitral mechanical heart valves
Abbott mitral valve surgical repair solutions

MITRAL VALVE REPAIR SOLUTIONS

SURGICAL REPAIR
MITRAL VALVE

Abbott offers a comprehensive portfolio of mitral valve repair products from a single source. These customizable repair products are suitable for implant using open sternotomy and minimally invasive approaches such as robotic surgery.

Learn more about Repair Solutions

MAT-2114940 v1.0 | Item approved for U.S. use only.

Important Safety Information
  • Epic PLUS
  • Trifecta GT
  • Regent
  • Masters Series
  • TAILOR RING/BAND
  • ATTUNE™ RING
  • SÉGUIN RING
  • RIGID SADDLE RING

  • 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 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.

  • 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 TAILOR™ ANNULOPLASTY RING OR
    SJM TAILOR™ ANNULOPLASTY BAND

    INDICATIONS

    The ring/band is indicated for use in the repair of a mitral or tricuspid valve that is diseased or damaged due to acquired or congenital valvular disease. It is the responsibility of the surgeon to determine that the valve is repairable. The decision to undertake annuloplasty can be made only after visual analysis of the valve pathology. Only surgeons who have received appropriate training should perform valve repair using the ring/band.

    CONTRAINDICATIONS

    Use of the ring/band is contraindicated in cases where severe organic lesions with retracted chordae tendineae require valvular replacement, and where there are congenital malformations which lack valvular tissue. Additionally, use of the ring/band is contraindicated whenever the physician determines that the remaining functional valve tissue and valve support structures are not adequate to provide the required hemodynamic performance or structural strength. Use of the ring/band is contraindicated for active bacterial endocarditis.

    PRECAUTIONS

    • Sizers and accessories are supplied non-sterile, and must be cleaned and sterilized prior to each use.
    • Do not use cracked, crazed, deformed, or damaged sizer set components.
    • Do not bend sizers beyond a 90° angle.
    • Prior to using the sizers in the SJM Tailor™ & Attune™ ring robotic sizer set model TAR-510R, secure a suture to the sizer using the safety suture hole (see Figure 2). The suture should be long enough to remain outside the patient at all times the sizer is inside the patient. In the event that the sizer is dropped inside the patient, the safety suture can be used to retrieve the sizer.
    • Do not use a ring/band if the “USE BY” date on the packaging has passed.
    • The contents of the tray in which the ring/band is supplied have been sterilized. Ensure the tray is unopened and unbroken. If you note any damage, do not use the device, and contact St. Jude Medical™ Customer Service.
    • Remove the identification tag and suture prior to implantation. Avoid cutting or tearing the ring/ band during removal of the identification tag and suture.
    • Do not place sutures in the circumflex coronary artery or in the right coronary artery.
    • Do not place sutures in the atrial tissue, as this may result in impairment of the cardiac conduction system.
    • After selecting the appropriate size ring, should the surgeon elect to convert the ring to a C-band, the ring must be cut within the designated cut area. The cut area is identified by the two notched windows on the ring holder just inside the trigone indicator tabs. Once the ring has been cut, remove the cut segment prior to implantation of the ring.
    • After the ring has been cut and the cut segment removed, care should be taken to remove any loose suture within the cut area prior to implantation of the ring.
    • To avoid damage to the fabric covering the ring/ band, cutting edge needles should not be used, and manipulation with forceps should be avoided during implantation.
    • If an implant suture inadvertently pierces a ring/ band retaining loop, the holder may not release from the ring/band. To facilitate release, cut the retaining loop suture close to the implant suture.
    • Remove any loose suture or thread, which may be a source of thrombus or thromboembolism.
    • Prophylactic antibiotic treatment should be
    • considered for all patients undergoing dental or other potentially bacteremic procedures.
       

    POTENTIAL ADVERSE EVENTS

    As with prosthetic heart valves, serious complications may be associated with the use of this device, sometimes leading to death. Complications necessitating reoperation may occur at varying intervals and include: thrombus; hemolysis; left ventricular outflow tract obstruction; systolic anterior motion; damage to coronary arteries; stenosis; uncorrected or recurrent regurgitation; partial or complete dislodgment of the ring/band from its site of attachment; thromboembolism; A-V block; endocarditis; low cardiac output; and bleeding disorders relating to the use of anticoagulant therapy.

  • ATTUNE™ FLEXIBLE ADJUSTABLE
    ANNULOPLASTY RING

    INDICATIONS

    The Attune™ Flexible Adjustable Annuloplasty Ring is indicated for use in the repair of a mitral or tricuspid valve that is diseased or damaged due to acquired or congenital valvular disease. It is the responsibility of the surgeon to determine that the valve is repairable and does not require replacement. The decision to undertake annuloplasty can be made only after visual analysis of the valve pathology. Only surgeons who have received appropriate training should perform valve repair using an Attune™ Ring.

    CONTRAINDICATIONS

    Use of the Attune™ Flexible Adjustable Annuloplasty Ring is contraindicated in cases where severe organic lesions with retracted chordae tendineae require valvular replacement, and where there are congenital malformations which lack valvular tissue. Additionally, use of the Attune™ Ring is contraindicated whenever the physician determines that the remaining functional valve tissue and valve support structures are not adequate to provide the required hemodynamic performance or structural strength. Use of the Attune™ Ring is contraindicated for active bacterial endocarditis.

    PRECAUTIONS

    • Do not use an Attune™ Flexible Adjustable
    • Annuloplasty Ring if the “USE BY” date on the packaging has passed.
    • Examine the device packaging carefully, and ensure the tray is unopened and unbroken. If you note any damage, do not use the device, and contact St. Jude Medical™ Customer Service.
    • Sizers are supplied non-sterile and must be cleaned and sterilized prior to each use.
    • Do not used cracked, crazed, corroded, deformed, damaged, or degraded sizer set components.
    • Prior to using the sizers in the SJM Tailor™ & Attune™ Ring Robotic Sizer Set models TAR-510R or
    • TAR-505R, secure a suture to the sizer using the safety suture hole. The suture should be long enough to remain outside the patient at all times the sizer is inside the patient. In the event that the sizer is dropped inside the patient, the safety suture can be used to retrieve the sizer.
    • Remove the Attune™ Ring from the support prior to implantation.
    • Remove the identification tag and suture prior to implantation. Avoid cutting or tearing the Attune™ Ring when removing the identification tag and suture.
    • Do not cut the Attune™ Ring.
    • To avoid damage to the Attune™ Ring, do not us cutting edge needles, and exercise care when holding or manipulating the Attune™ Ring with forceps.
    • Implantation of the Attune™ Ring has not been evaluated with the use of nitinol clips.
    • Do not place suture(s) through the posterior portion of the Attune™ Ring prior to finalizing and securing the adjustment, as this may result in disabling the adjustment suture.
    • Do not place sutures in the circumflex coronary artery or in the right coronary artery.
    • Do not place sutures in the atrial tissue, as this may result in impairment of the cardiac conduction system. Remove any loose suture or thread, which may be a source of thrombus or thromboembolism.
    • Prophylactic antibiotic treatment should be considered for all patients undergoing dental procedures.

    POTENTIAL ADVERSE EVENTS

    As with prosthetic heart valves, serious complications may be associated with the use of this device, sometimes leading to death. Complications necessitating reoperation may occur at varying intervals and include: thrombus; hemolysis; left ventricular outflow tract obstruction; systolic anterior motion; damage to coronary arteries; stenosis; uncorrected or recurrent regurgitation; partial or complete dislodgment of the Attune™ Ring from its site of attachment; thromboembolism; A-V block; endocarditis; low cardiac output; and bleeding disorders relating to the use of anticoagulant therapy.

  • SJM™ SÉGUIN ANNULOPLASTY RING / SJM™ SÉGUIN
    ANNULOPLASTY RING SIZER SET MODEL SAR-501

    INDICATIONS

    The SJM™ Séguin Annuloplasty Ring is indicated for use in the repair of mitral valves that are diseased or damaged due to acquired or congenital processes. It is the responsibility of the surgeon to determine that the valve is repairable and does not require replacement. The decision to undertake annuloplasty can be made only after visual analysis of the valve pathology. Only surgeons who have received appropriate training should perform valve repair using the SJM™ Séguin Annuloplasty Ring. The SJM™ Séguin Annuloplasty Ring Sizer Set Model SAR-501 is indicated for use with the SJM™ Séguin Annuloplasty Ring.

    CONTRAINDICATIONS

    Use of the SJM™ Séguin Annuloplasty Ring is contraindicated in cases where severe organic lesions with retracted chordae tendineae require valvular replacement and where there are congenital malformations which lack valvular tissue. Additionally, use of the ring is contraindicated whenever the physician determines that the remaining functional valve tissue and valve support structures are not adequate to provide the required hemodynamic performance or structural strength. Use of the SJM™ Séguin Annuloplasty Ring is contraindicated for active bacterial endocarditis. Use of the SJM™ Séguin Annuloplasty Ring Sizer Set Model SAR-501 with products other than the SJM™ Séguin Annuloplasty Ring is contraindicated. When sterilizing the SAR-501 sizer set, any sterilization method other than steam is contraindicated.

    PRECAUTIONS

    • SJM™ Séguin Annuloplasty Ring
    • Do not use the ring if the “USE BY” date on the packaging has passed.
    • Examine the device packaging carefully, and ensure the pouch is unopened and unbroken. If you note any damage, do not use the device, and contact St. Jude Medical™ customer service.
    • Remove the identification tag and suture prior to implantation. Avoid cutting or tearing the ring during removal of the identification tag and suture.
    • Do not place sutures in the circumflex coronary artery or in the right coronary artery.
    • Do not place sutures in the atrial tissue, as this may result in impairment of the cardiac conduction system.
    • Do not attempt to deform or otherwise alter the configuration of the prosthetic ring to conform to a specific annular anatomy, as this could damage the ring. If the ring is not suitably sized for the annulus, a larger or smaller ring should be chosen.
    • To avoid damage to the fabric covering the ring, do not use cutting edge needles, and avoid manipulation with forceps during implantation.
    • Remove any loose suture or thread, which may be a source of thrombus or thromboembolism.
    • Prophylactic antibiotic treatment should be considered for all patients undergoing dental or other potentially bacteremic procedures.
    • SJM™ Séguin Annuloplasty Ring Sizer Set
    • Model SAR-501
    • All sizer set components are supplied non-sterile, and must be cleaned and steam sterilized prior to each use.
    • The sterilization temperature must not exceed 138°C (280°F).
    • The autoclavable tray and cover do not provide a sterile barrier.
    • Do not use cracked, deformed, or damaged sizer set components.
    • Do not bend handles beyond a 90° angle.
    • Do not expose sizer set components to cleaning or rinse agents that are not compatible with polysulfone or polyphenylsulfone.

    POTENTIAL ADVERSE EVENTS

    As with prosthetic heart valves, serious complications may be associated with the use of this device, sometimes leading to death. Complications necessitating re-operation may occur at varying intervals and include: thrombus; hemolysis; ring fracture; left ventricular outflow tract obstruction; systolic anterior motion; damage to coronary arteries; stenosis; uncorrected or recurrent regurgitation; partial or complete dislodgment of the ring from its site of attachment; thromboembolism; A-V block; endocarditis; low cardiac output; and bleeding disorders relating to the use of anticoagulant therapy.

  • SJM™ RIGID SADDLE RING
    INDICATION FOR USE

    The SJM™ Rigid Saddle Ring is indicated for use to correct annular dilation, increase leaflet coaptation, and prevent further dilation of the mitral valve annulus caused by disease states such as degenerative disease, rheumatic disease, ischemia, or vascular disease. The combination of prosthetic ring with valvuloplasty may be used in all acquired or congenital mitral insufficiencies with dilation and deformation of the fibrous mitral annulus. For mitral insufficiencies with no subvalvular lesions and normal valvular movements, prosthetic ring implant alone may be sufficient. However, annuloplasty ring implant along with mitral valvuloplasty repair must be considered for insufficiencies with a prolapsed valve due to elongation or rupture of the chordae tendineae and for insufficiencies with limitation of valvular movements due to fusion of the commissures or chordae tendineae, or chordal hypertrophy.

    CONTRAINDICATIONS

    Use of the SJM™ Rigid Saddle Ring is contraindicated in cases where severe organic lesions with retracted chordae tendineae require valvular replacement and where there are congenital malformations which lack valvular tissue. Additionally, use of the ring is contraindicated whenever the physician determines that the remaining functional valve tissue and valve support structures are not adequate to provide the required hemodynamic performance or structural strength. Use of the SJM Rigid Saddle Ring is contraindicated for active bacterial endocarditis.

    SUMMARY OF PRECAUTIONS

    • Do not use a ring if the “USE BEFORE” date on the packaging has passed.
    • The contents of the tray in which the ring is supplied have been sterilized. Ensure the tray
    • and the seal are unopened and unbroken.
    • Remove the serial number tag and suture prior to implantation. Exercise care to avoid cutting or tearing the ring during removal of the identification tag.
    • Do not place sutures in the circumflex coronary artery or in the right coronary artery.
    • Sutures should not be placed in any atrial tissue, as impairment of cardiac conduction may occur.
    • Sizers are supplied non-sterile, and must be cleaned and sterilized prior to each use. Do not use cracked or deformed sizers.
    • To avoid damage to the fabric covering the ring, cutting edge needles should not be used and manipulation with sharp-toothed metal forceps should be avoided during implantation.
    • If an implant suture inadvertently pierces a ring retaining loop, the holder may not release from the ring. To facilitate release, cut the retaining loop suture close to the implant suture.
    • Take care to remove any loose suture or thread, which may be a source of thrombus or thromboembolism.
    • Do not alter or deform ring to conform to the anatomy.
    • Prophylactic antibiotic treatment should be considered for all patients undergoing dental or other potentially bacteremic procedures.

    SURGICAL CONSIDERATIONS

    • Suture techniques may vary according to the preferences of the implanting surgeon and the needs of the patient. Please consult the references listed in this manual for further informatio regarding surgical options for mitral valve repair. 1,2,3
    • To avoid distortion of the patient’s annulus, it is important to maintain even suture spacing within the annular tissue.
    • It is imperative to retain correct positioning of the leaflets relative to the SJM Rigid Saddle Ring. The SJM Rigid Saddle Ring commissure markers and posterior marker should be used as reference points for reconstruction of the annulus.
    • To securely anchor the sutures in the sewing cuff, place the sutures slightly outside of the running green suture marker. Sutures anchoring the ring must be placed so as to engage the fibrous tissue that connects the base of the leaflet, the atrium, and the orifice of the ventricle.
    • To ensure adequate distribution of suture stresses in patients with cardiomyopathy, numeroussutures should be used to secure the ring.1
    • Intraoperative echocardiography is recommended to assess valvular competency and quality of mitral repair.
    • Once all sutures have been placed on the cuff, the ring may be parachuted down into the annulus. If desired, the ring holder may be used to maintain the shape of the ring while the sutures are tied off. To facilitate ty-ing, the handle may be removed from the ring holder by using a forceps to depress the release button. Once all of the sutures have been tied, the handle may be reattached to the holder to facilitate removal. To remove the ring holder, cut the retaining suture.
    • After the ring has been implanted, depress the release button to remove the ring delivery system. The ring holder should be discarded.
    • CAUTION: To avoid damage to the fabric covering the ring, cutting edge needles and sharp-toothed forceps should not be used during implantation.
    • CAUTION: If an implant suture inadvertently pierces a ring retaining loop, the holder may not release from the ring. To facilitate release, cut the retaining loop suture close to the implant suture. Take care to remove any loose material.

    POTENTIAL SIDE EFFECTS

    As with prosthetic heart valves, serious complications may be associated with the use of this device, sometimes leading to death. Complications necessitating reoperation may occur at varying intervals and include: thrombus hemolysis; ring fracture; left ventricular outflow tract obstruction; systolic anterior motion; damage to coronary arteries; stenosis; uncorrected or recurrent regurgitation; partial or complete dislodgment of the ring from its site of attachment; thromboembolism; A-V block; endocarditis; low cardiac output; and bleeding disorders relating to the use of anticoagulant therapy.

    1. Romano, Mathew A. and Bolling, Steven F., Mitral Valve Repair as an Alternative Treatment for Heart Failure Patients. Heart Failure Monitor, 4(1): 7-12, 2003.
    2. Carpentier, A., Mitral Valve Reconstructive Surgery. Operative Surgery, 3rd Edition. Butterworths Publishers, 169-177, 1977.
    3. Carpentier, A. Cardiac Valve Surgery-The French Correction. J. Thorac. Cardiovasc. Surg., 86:323-377, 1983.

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