Surgical Aortic

Pericardial Valves

Surgical Aortic

Pericardial Valves

The Carpentier-Edwards aortic pericardial valve portfolio is built upon the PERIMOUNT bioprosthesis design.

MODEL 3300TFX
CARPENTIER-EDWARDS

MAGNA EASE

Pericardial Aortic Bioprosthesis
MODEL 3300TFX
FEATURES

Lowered profile
Ease of Implant
Supra-annular design
Upsize potential
Bioengineered
Flexible CoCr alloy stent
Pericardial leaflets
ThermaFix process
MODELS 3000/3000TFX
CARPENTIER-EDWARDS

MAGNA

Pericardial Aortic Bioprosthesis
MODELS 3000/3000TFX
FEATURES

Supra-annular design
Upsize potential
Bioengineered
Flexible CoCr alloy stent
Pericardial leaflets
ThermaFix process
MODELS 2800/2800TFX
CARPENTIER-EDWARDS

PERIMOUNT RSR

Pericardial Aortic Bioprosthesis
MODELS 2800/2800TFX
FEATURES

Reduced sewing ring
Bioengineered
Flexible CoCr alloy stent
Pericardial leaflets
ThermaFix process
MODELS 2700/2700TFX
CARPENTIER-EDWARDS

PERIMOUNT

Pericardial Aortic Bioprosthesis
MODELS 2700/2700TFX
FEATURES

Bioengineered
Flexible CoCr alloy stent
Pericardial leaflets
ThermaFix process



No clinical data are available that evaluate the long-term impact of the Edwards Lifesciences tissue treatments in patients.

MAGNA Ease Valve

Carpentier-Edwards PERIMOUNT Magna Ease Aortic Heart Valve

Exceptional Long-Term Durability

  • Built on the proven performance of the PERIMOUNT valve design, with published clinical durability of up to 20 years
  • Magna Ease valves have been tested in vitro to over one billion cycles

Proven PERIMOUNT Design

  • The Magna Ease valve is built upon the proven, time-tested PERIMOUNT valve design, with unique design elements including:

Ease of Implant

  • Offers many key design features that enhance the valve's ease of implant

Excellent and Stable Hemodynamics

  • Excellent EOAs and low gradients documented in published studies1-3
  • Documented hemodynamic stability up to 17 years post-implantation

Exceptional Long-Term Durability

  • Built on the proven performance of the PERIMOUNT valve design, with published clinical durability of up to 20 years
Proven PERIMOUNT Design
Ease of Implant
Excellent and Stable Hemodynamics
Exceptional Long-Term Durability

Magna Ease Aortic Valve

Indications

The Carpentier-Edwards PERIMOUNT Magna Ease pericardial aortic bioprosthesis is intended for use in patients whose aortic valvular disease is sufficiently advanced to warrant replacement of their natural valve with a prosthetic one. It is also intended for use in patients with a previously implanted aortic valve prosthesis that is no longer functioning adequately and requires replacement. In the latter case, the previously implanted prosthesis is surgically excised and replaced by the replacement prosthesis.

Materials List

  • Valve leaflets: Bovine pericardium
  • Stent: Cobalt-chromium alloy
  • Fabric covering stent: Polyester cloth
  • Valve sewing ring: Silicone rubber

Tissue Treatment

  • Model 3300TFX features the Carpentier-Edwards ThermaFix process, which confronts both major calcium binding sites: residual glutaraldehydes and phospholipids

General Product Information

  • Storage Temperature: 10 °C to 25 °C (50-77 °F)
  • Storage Solution: Glutaraldehyde
  • Rinse Procedure: 500 ml (sterile physiological saline solution) x 60 seconds. Repeat once using new saline solution

ModelDescriptionSizesImage
3300TFX Carpentier-Edwards
PERIMOUNT Magna Ease
pericardial aortic bioprosthesis
with ThermaFix process
19, 21, 23, 25, 27, & 29 mm Carpentier-Edwards 
PERIMOUNT Magna Ease
pericardial aortic bioprosthesis
with ThermaFix process‡

ModelDescriptionCompatible with Valve ModelsSizes
1133SET Sizers – Complete Set 3300TFX 19, 21, 23, 25, 27, and 29 mm
1133 Sizers - Individual 3300TFX 19, 21, 23, 25, 27, and 29 mm
 TRAY1133  Accessory Tray 3300TFX N/A
 1111  Reusable Handle 3300TFX, 3000TFX, 3000, 2800TFX, 2800, 2700TFX, 2700 N/A
 1126  Longer Single-Use Handle 3300TFX, 3000TFX, 3000, 2800TFX, 2800, 2700TFX, 2700 N/A

CLINICAL COMMUNIQUé

20 YEAR RESULTS
Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis.

download now
(1.14MB)



‡ No clinical data are available that evaluate the long-term impact of the Edwards Lifesciences tissue treatments in patients.
* Freedom from explant / prosthesis replacement / reoperation due to SVD.
† Freedom from valve reoperation for prosthesis dysfunction and all other causes.

References:
  1. Dalmau M, et al. The Carpentier-Edwards Perimount Magna aortic xenograft: a new design with an improved hemodynamic performance. Interactive Cardiovasc and Thoracic Surgery 2006;5:263–267.
  2. Ruzicka D, et al. The Complete Supraannular Concept, In Vivo Hemodynamics of Bovine and Porcine Aortic Bioprostheses. Circulation 2009;120(11 Suppl):S139-45.
  3. Wendt D, et al. The new St Jude Trifecta versus Carpentier-Edwards Magna and Magna Ease aortic bioprosthesis: Is there a hemodynamic superiority? J Thorac Cardiovasc Surg. 2014;147(5):1553-1560.
  4. Banbury MK et al. Hemodynamic Stability During 17 Years of the Carpentier-Edwards Aortic Pericardial Bioprosthesis. Ann Thorac Surg 2002;73:1460-65. (Cohort size = 267, mean age = 65 yrs.)
  5. Pelletier LC, Carrier M, Leclerc Y, et al. The Carpentier-Edwards Pericardial Bioprosthesis: Clinical Experience with 600 Patients. Ann Thorac Surg. 1995;60:S297-302. (Cohort size = 416, mean age = 63 yrs. Number at risk for Primary Valve Dysfunction at last follow-up = 18)
  6. Cosgrove DM, Lytle BW, Taylor PC, et al. The Carpentier-Edwards Pericardial Aortic Valve. Ten-year results. J Thorac Cardiovasc Surg. 1995;110(3):651 662. (Cohort size = 310; mean age = 64.2 ± 10. 8 yrs. Number at risk for Structural Valve Deterioration at last follow-up = 63)
  7. Carrier M, Pellerin M, Perrault LP, et al. Aortic Valve Replacement with Mechanical and Biologic Prosthesis in Middle-aged Patients. Ann Thorac Surg. 2001;71:S253-256. (Cohort size = 158, mean age = 61 ± 3 yrs. Number at risk for Valve Dysfunction at last follow-up not reported)
  8. Murakami T, et al. Aortic and Mitral Valve Replacement with the Carpentier-Edwards Pericardial Bioprosthesis: 10-year Results. J Heart Valve Dis. 1996 Jan;5(1):45-9. (Cohort size = 49, mean age = 58.6 ± 15.1 yrs. Number at risk for SVD at last follow-up = 1)
  9. Aupart MR, Babuty DG, Guesnier L, et al. Double Valve Replacement with the Carpentier-Edwards Pericardial Valve: 10-year Results. J Heart Valve Dis. 1996;5(3):312-316. (Cohort size = 71, mean age = 63.4 yrs. Number at risk for Valve Structural Failure at last follow-up not reported)
  10. Aupart MR, Sirinelli AL, Diemont FF, et al. The Last Generation of Pericardial Valves in the Aortic Position: Ten-year Follow-up in 589 Patients. Ann Thorac Surg. 1996;61(2):615-620. (Cohort size = 589, mean age = 67.5 ± 11.2 yrs. Number at risk for Structural Valve Failure at last follow-up not reported)
  11. Aupart M, Simonnot I, Sirinelli A, et al. Pericardial Valves in Small Aortic Annuli: Ten Years’ Results. Eur J Cardiothorac Surg. 1996;10(10):879-883. (Cohort size = 90, mean age = 72.2 ± 10.1 yrs. Number at risk for Valve Failure at last follow-up not reported)
  12. Gao G, Wu Y, Grunkemeier GL, et al. Durability of Pericardial Versus Porcine Aortic Valves. J Am Coll Cardiol. 2004;44(2):384-388. (Cohort size = 1,021, mean age = 74 yrs. Number at risk for Explant for SVD at last follow-up = 6)
  13. Le Tourneau T, Vincentelli A, Fayad G, et al. Ten-year Echocardiographic and Clinical Follow-up of Aortic Carpentier-Edwards Pericardial and Supraannular Prosthesis: a Case-match Study. Ann Thorac Surg. 2002;74(6):2010-2015. (Cohort size = 75, mean age = 72 ± 9 yrs. Number at risk for SVD or reoperation at last follow-up = 18)
  14. Banbury MK, Cosgrove DM III, Lytle BW, Smedira NG, Sabik JF, Saunders CR. Long-term Results of the Carpentier-Edwards Pericardial Aortic valve: A 12-year Follow-up.Ann Thorac Surg 1998;66:S73–6. (Cohort size = 310, mean age = 64.2 ± 10.8 yrs. Number at risk for Structural Deterioration at last followup = 111)
  15. Dellgren G, David TE, Raanani E, Armstrong S, Ivanov J, Rakowski H. Late Hemodynamic and Clinical Outcomes of Aortic Valve Replacement with the Carpentier-Edwards Perimount Pericardial Bioprosthesis. J Thorac Cardiovasc Surg 2002;124:146-54. (Cohort size = 254, mean age = 71 yrs. Number at risk for Structural Valve Dysfunction at last follow-up = 6)
  16. Nakajima H, Aupart MR, Neville PH, Sirinelli AL, Meurisse YA, Marchand MA. Twelve-year Experience with the 19 mm Carpentier-Edwards Pericardial Aortic Valve. J Heart Valve Dis 1998;7:534-539. (Cohort size = 121, mean age = 73.2 ± 9.4 yrs. Number at risk for Structural Valve Deterioration at last follow-up = 4)
  17. Neville PH, et al. Carpentier-Edwards Pericardial Bioprosthesis in Aortic or Mitral Position: a 12-year Experience. Ann Thorac Surg. 1998;66(6 Suppl):S143-7. (Cohort size = 787, mean age = 68.83± 10.8` yrs. Number at risk for Structural Deterioration at last follow-up = 13)
  18. Pellerin M, Mihaileanu S, Couetil JP, Relland JYM, Deloche A, Fabiani JN, Jindani A, Carpentier AF. Carpentier-Edwards Pericardial Bioprosthesis in Aortic Position: Long-term Follow-up 1980 to 1994. Ann Thorac Surg. 1995;60:S292-6. (Cohort size = 124, mean age = 65 yrs. Number at risk for Structural Valve Deterioration at last follow-up = 8)
  19. Frater RWM, Furlong P, Cosgrove DM, Okies JE, Colburn LQ, Katz AS, Lowe NL, Ryba EA. Long-term Durability and Patient Functional Status of the Carpentier-Edwards Perimount Pericardial Bioprosthesis in the Aortic Position. J Heart Valve Dis. 1998;7:48-53. (Cohort size = 267, mean age = 64.9 ± 11.8 yrs. Number at risk for Valve Dysfunction at last follow-up = 28)
  20. Poirier NC, et al. 15-year Experience with the Carpentier-Edwards Pericardial Bioprosthesis. Ann Thorac Surg. 1998;66:S57-61. (Cohort size = 598, mean age = 65 yrs. Number at risk for Structural Deterioration at last follow-up = 8)
  21. Banbury MK, Cosgrove DM III, White JA, et al. Age and Valve Size Effect on the Long-term Durability of the Carpentier-Edwards Aortic Pericardial Bioprosthesis. Ann Thorac Surg. 2001;72(3):753-757. (Cohort size = 267, mean age = 65 ± 12 yrs. Number at risk for Explant for SVD at last follow-up not reported)
  22. McClure RS, Narayanasamy N, Wiegerinck E, et al. Late Outcomes for Aortic Valve Replacement with the Carpentier-Edwards Pericardial Bioprosthesis: Up to 17-year Follow-up in 1,000 Patients. Ann Thorac Surg. 2010;89(5):1410-1416. (Cohort size = 1,000, mean age = 74.1 ± 0.29 yrs. Number at risk for SVD at last follow-up not reported)
  23. Minakata K et al. Long-Term Outcome of the Carpentier-Edwards Pericardial Valve in the Aortic Position in Japanese Patients. Circulation Journal 2014;78:882-889. (Cohort size = 574, mean age = 71.9 yrs. Number at risk for Structural Deterioration at 15-year follow-up = 54)
  24. Jamieson WR, Germann E, Aupart MR, et al. 15-year Comparison of Supra-annular Porcine and PERIMOUNT Aortic Bioprostheses. Asian Cardiovasc Thorac Ann. 2006;14(3):200-205. (Cohort size = 1,430, mean age = 69.5 ± 10.4 yrs. Number at risk for SVD at last follow-up = 33)
  25. Biglioli P, Spampinato N, Cannata A, et al. Long-term outcomes of the Carpentier-Edwards pericardial valve prosthesis in the aortic position: effect of patient age. J Heart Valve Dis. 2004;13(1):S49-51. (Cohort size = 327, mean age = 67.2 ± 10.6 yrs. Number at risk for Prosthesis Replacement at last follow-up not reported)
  26. Bergoënd E, Aupart MR, Mirza A, et al. 20 years’ durability of Carpentier-Edwards Perimount stented pericardial aortic valve. In: Yankah CA, Weng Y, Hetzer R, eds. Aortic Root Surgery The Biological Solution. Berlin: Springer; 2010:441-451. (Cohort size = 1,857, mean age = 69.8 yrs, Number at risk for Structural Valve Deterioration at last follow-up not reported)
  27. Aupart MR, Mirza A, Meurisse YA, et al. Perimount Pericardial Bioprosthesis for Aortic Calcified Stenosis: 18-year Experience with 1133 Patients. J Heart Valve Dis. 2006;15(6):768-775. (Cohort size = 1,133, mean age = 72.6 yrs. Number at risk for SVD at last follow-up = 2)
  28. Forcillo J et al. Carpentier-Edwards Pericardial Valve in the Aortic Position: 25-Years Experience. Ann Thorac Surg 2013;96:486-93. (Cohort size = 2,405, mean age = 71 yrs. Number at risk for Structural Deterioration at last follow-up = 30)
  29. Carpentier-Edwards PERIMOUNT Aortic Pericardial Bioprosthesis 20-year Results. Data on file at Edwards Lifesciences, 2003. (Cohort size = 267, mean age = 65 ± 12 yrs. For patients ≥65, number at risk for explant due to SVD at last follow-up = 2)
MAGNA VALVE

Carpentier-Edwards PERIMOUNT Magna Aortic Heart Valve

The Magna valve (bioprosthesis) has a true supra-annular design for optimal hemodynamics and flow characteristics.

  • Enables up to 23% greater effective orifice area (EOA)**
  • Demonstrates exceptional hemodynamic performance with a very low risk of patient-prosthesis mismatch30
  • Designed on the foundation of the PERIMOUNT aortic valve, with published clinical durability of up to 20 years
  • Treated with the Carpentier-Edwards ThermaFix process, which confronts both major calcium binding sites: residual glutaraldehydes and phospholipids

Magna Aortic Valve

Magna Aortic Valve

Design

  • Mathematically modeled, bioengineered design - optimized for hemodynamics, durability and implantability
  • Flexible cobalt-chromium alloy stent - absorbs energy to reduce leaflet stress
  • Three independent bovine pericardial leaflets - matched for thickness and elasticity to optimize stress distribution

Indications

The Carpentier-Edwards PERIMOUNT Magna pericardial aortic bioprosthesis is intended for use in patients whose aortic valvular disease is sufficiently advanced to warrant replacement of their natural valve with a prosthetic one. It is also intended for use in patients with a previously implanted aortic valve prosthesis that is no longer functioning adequately and requires replacement. In the latter case, the previously implanted prosthesis is surgically excised and replaced by the replacement prosthesis.

Materials List

  • Valve leaflets: Bovine pericardium
  • Stent: Cobalt-chromium alloy
  • Fabric covering stent: Polyester cloth
  • Valve sewing ring: Silicone rubber

Tissue Treatment

  • Model 3000TFX features the Carpentier-Edwards ThermaFix process, which confronts both major calcium binding sites: residual glutaraldehydes and phospholipids
  • Model 3000 features the XenoLogiX treatment, a two-step process targeting residual phospholipids

General Product Information

  • Storage Temperature: 10 °C to 25 °C (50-77 °F)
  • Storage Solution: Glutaraldehyde
  • Rinse Procedure: 500 ml (sterile physiological saline solution) x 60 seconds. Repeat once using new saline solution

ModelDescriptionSizesImage
3000TFX Carpentier-Edwards
PERIMOUNT Magna
pericardial aortic bioprosthesis
with ThermaFix process
19, 21, 23, 25, 27, & 29 mm 3000TFX
3000 Carpentier-Edwards
PERIMOUNT Magna
pericardial aortic bioprosthesis
19, 21, 23, 25, 27, & 29 mm 3000


Sizers and Accessories
Model 1130SET Complete sizer set
Model 1130SET
Model 1130 Sizers – Individual
Model 1130
Model Tray1130 Accessory Tray
Model 1111 Reusable handle
Model 1111
Model 1126 Single-use handle (extended length)
Model 1126

CLINICAL COMMUNIQUé

20 YEAR RESULTS
Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis.

download now
(1.14MB)



No clinical data are available that evaluate the long-term impact of the Edwards Lifesciences tissue treatments in patients.
** Compared to a PERIMOUNT valve with the same external sewing ring diameter.

References:
  1. Magna Ease valve Instructions for Use
PERIMOUNT RSR VALVE

Carpentier-Edwards PERIMOUNT RSR Aortic Heart Valve

The Carpentier-Edwards PERIMOUNT RSR aortic valve combines a proven design with the benefits of pericardial tissue.
  • Designed on the foundation of the PERIMOUNT aortic valve, with published clinical durability of up to 20 years
  • PERIMOUNT aortic valves are supported by 17 years of proven hemodynamic stability

Proven Design

  • Mathematically modeled, bioengineered design - optimized for hemodynamics, durability and implantability
  • Flexible cobalt-chromium alloy stent - absorbs energy to reduce leaflet stress
  • Three independent bovine pericardial leaflets - matched for thickness and elasticity to optimize stress distribution

PERIMOUNT RSR Aortic Valve

PERIMOUNT RSR Aortic Valve

Indications

The Carpentier-Edwards PERIMOUNT pericardial aortic bioprosthesis is intended for use in patients whose aortic valvular disease is sufficiently advanced to warrant replacement of their natural valve with a prosthetic one. It is also intended for use in patients with a previously implanted aortic valve prosthesis that is no longer functioning adequately and requires replacement. In the latter case, the previously implanted prosthesis is surgically excised and replaced by the replacement prosthesis.

Materials List

  • Valve leaflets: Bovine pericardium
  • Stent: Cobalt-chromium alloy
  • Fabric covering stent: Polyester cloth
  • Valve sewing ring: Silicone rubber

Tissue Treatment

  • Model 2800TFX features the Carpentier-Edwards ThermaFix process, which confronts both major calcium binding sites: residual glutaraldehydes and phospholipids
  • Model 2800 features the XenoLogiX treatment, a two-step process targeting residual phospholipids

General Product Information

  • Storage Temperature: 10 °C to 25 °C (50-77 °F)
  • Storage Solution: Glutaraldehyde
  • Rinse Procedure: 500 ml (sterile physiological saline solution) x 60 seconds
    Repeat once using new saline solution

  Model  DescriptionSizeImage
2800TFX Carpentier-Edwards 
PERIMOUNT RSR
pericardial aortic bioprosthesis
with ThermaFix process
19, 21, 23, 25, 27, & 29 mm 2800TFX
2800 Carpentier-Edwards 
PERIMOUNT RSR
pericardial aortic bioprosthesis
19, 21, 23, 25, 27, & 29 mm 2800

  Model  DescriptionCompatible with Valve ModelsSizes
 1161-SET  TRUE-SIZE Sizers - Complete Set 2800TFX, 2800 Includes All
 1161  TRUE-SIZE Sizers - Individual 2800TFX, 2800 19, 21, 23, 25, 27, and 29
 TRAY1161  Accessory Tray 2800TFX, 2800, 2700TFX, 2700 N/A
 1111  Reusable Handle 3300TFX, 3000TFX, 3000, 2800TFX, 2800, 2700TFX, 2700 N/A
 1126  Longer Single-Use Handle 3300TFX, 3000TFX, 3000, 2800TFX, 2800, 2700TFX, 2700 N/A

CLINICAL COMMUNIQUé

20 YEAR RESULTS
Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis.

download now
(1.14MB)



‡ No clinical data are available that evaluate the long-term impact of the Edwards Lifesciences tissue treatments in patients.

PERIMOUNT VALVE

Carpentier-Edwards PERIMOUNT Aortic Heart Valve

The Carpentier-Edwards PERIMOUNT aortic valve is the first biomechanically engineered valve designed specifically for the aortic position. It combines a proven design with the benefits of pericardial tissue.
  • The PERIMOUNT aortic valve delivers excellent performance with proven published durability of up to 20 years
  • PERIMOUNT aortic valves are supported by 17 years of proven hemodynamic stability

Proven Design

  • Mathematically modeled, bioengineered design - optimized for hemodynamics, durability and implantability
  • Flexible cobalt-chromium alloy stent - absorbs energy to reduce leaflet stress
  • Three independent bovine pericardial leaflets - matched for thickness and elasticity to optimize stress distribution

PERIMOUNT Aortic Valve

PERIMOUNT Aortic Valve

Indications

The Carpentier-Edwards PERIMOUNT pericardial aortic bioprosthesis is intended for use in patients whose aortic valvular disease is sufficiently advanced to warrant replacement of their natural valve with a prosthetic one. It is also intended for use in patients with a previously implanted aortic valve prosthesis that is no longer functioning adequately and requires replacement. In the latter case, the previously implanted prosthesis is surgically excised and replaced by the replacement prosthesis.

Materials List

  • Valve leaflets: Bovine pericardium
  • Stent: Cobalt-chromium alloy
  • Fabric covering stent: Polyester cloth
  • Valve sewing ring: Silicone rubber

Tissue Treatment

  • Model 2700TFX features the Carpentier-Edwards ThermaFix process, which confronts both major calcium binding sites: residual glutaraldehydes and phospholipids
  • Model 2700 features the XenoLogiX treatment, a two-step process targeting residual phospholipids

General Product Information

  • Storage Temperature: 10 °C to 25 °C (50-77 °F)
  • Storage Solution: Glutaraldehyde
  • Rinse Procedure: 500 ml (sterile physiological saline solution) x 60 seconds. Repeat once using new saline solution

  Model  DescriptionSizeImage
2700TFX Carpentier-Edwards 
PERIMOUNT
pericardial aortic bioprosthesis
with ThermaFix process
19, 21, 23, 25, 27, and 29 mm
2700 Carpentier-Edwards 
PERIMOUNT
pericardial aortic bioprosthesis
19, 21, 23, 25, 27, and 29 mm

  Model  DescriptionCompatible with Valve ModelsSizes
 1127-SET  Sizers - Complete Set 2700TFX, 2700 Includes All
 1127  Sizers - Individual 2700TFX, 2700 19, 21, 23, 25, 27, and 29 mm
 TRAY1161  Accessory Tray 2800TFX, 2800, 2700TFX, 2700 N/A
 1111  Reusable Handle 3300TFX, 3000TFX, 3000, 2800TFX, 2800, 2700TFX, 2700 N/A
 1126  Longer Single-Use Handle 3300TFX, 3000TFX, 3000, 2800TFX, 2800, 2700TFX, 2700 N/A

CLINICAL COMMUNIQUé

20 YEAR RESULTS
Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis.

download now
(1.14MB)



‡ No clinical data are available that evaluate the long-term impact of the Edwards Lifesciences tissue treatments in patients.

Important Safety Information

Brief Summary: Aortic Bioprostheses

Indications: For use in patients whose aortic valvular disease warrants replacement of their natural or previously placed prosthetic valve.

Important Safety Information

Brief Summary: Aortic Bioprostheses

Indications: For use in patients whose aortic valvular disease warrants replacement of their natural or previously placed prosthetic valve.

Contraindications: Do not use if surgeon believes it would be contrary to the patient’s best interests.

Complications and Side Effects: Stenosis, regurgitation, endocarditis, hemolysis, thromboembolism, valve thrombosis, nonstructural dysfunction, structural valve deterioration, anemia, arrhythmia, hemorrhage, transient ischemic attack/stroke, congestive heart failure, myocardial infarction, angina, any of which could lead to reoperation, explantation, permanent disability, and death.

Warnings: Alternative therapies should be considered in the presence of conditions affecting calcium metabolism or when calcium containing chronic drug therapies are used, including children, adolescents, young adults, and patients on a high calcium diet or maintenance hemodialysis. Should be used with caution in the presence of severe systemic hypertension or when anticipated patient longevity is longer than the known longevity of the prosthesis.

CAUTION: Federal (United States) law restricts this device to sale by or on the order of a physician. See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions and adverse events.

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