The Carpentier-Edwards aortic pericardial valve portfolio is built upon the PERIMOUNT bioprosthesis design.
CARPENTIER-EDWARDS
MAGNA EASE
Pericardial Aortic Bioprosthesis
MODEL 3300TFX
FEATURES
Lowered profile
Ease of Implant
Supra-annular design
Upsize potential
Ease of Implant
Supra-annular design
Upsize potential
Bioengineered
Flexible CoCr alloy stent
Pericardial leaflets
ThermaFix process ‡
Flexible CoCr alloy stent
Pericardial leaflets
ThermaFix process ‡
CARPENTIER-EDWARDS
MAGNA
Pericardial Aortic Bioprosthesis
MODEL 3000
FEATURES
Supra-annular design
Upsize potential
Upsize potential
Bioengineered
Flexible CoCr alloy stent
Pericardial leaflets
ThermaFix process ‡
Flexible CoCr alloy stent
Pericardial leaflets
ThermaFix process ‡
CARPENTIER-EDWARDS
PERIMOUNT
Pericardial Aortic Bioprosthesis
MODEL 2900
FEATURES
Bioengineered
Flexible CoCr alloy stent
Pericardial leaflets
ThermaFix process ‡
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
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
| Model | Description | Sizes | Image |
|---|---|---|---|
| 3300TFX | Carpentier-Edwards PERIMOUNT Magna Ease pericardial aortic bioprosthesis with ThermaFix process‡ |
19, 21, 23, 25, 27, & 29 mm |  |
| Model | Description | Compatible with Valve Models | Sizes |
|---|---|---|---|
| 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 | N/A |
| 1126 | Longer Single-Use Handle | 3300TFX, 3000TFX, 3000 | N/A |
Clinical summary:
Very long-term outcomes of the Carpentier-Edwards PERIMOUNT valve in aortic position
Download now
(230 KB)
‡ 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:
- 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.
- Ruzicka D, et al. The Complete Supraannular Concept, In Vivo Hemodynamics of Bovine and Porcine Aortic Bioprostheses. Circulation 2009;120(11 Suppl):S139-45.
- 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.
- 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.)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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
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 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
| Model | Description | Sizes | Image |
|---|---|---|---|
| 3000 | Carpentier-Edwards PERIMOUNT Magna pericardial aortic bioprosthesis |
19, 21, 23, 25, 27, & 29 mm |  |
| Sizers and Accessories | ||||
|---|---|---|---|---|
| Model 1130SET | Complete sizer set |
 |
||
| Model 1130 | Sizers – Individual |
 |
||
| Model Tray1130 | Accessory Tray |
 |
||
| Model 1111 | Reusable handle |
 |
||
| Model 1126 | Single-use handle (extended length) |
 |
Clinical summary:
Very long-term outcomes of the Carpentier-Edwards PERIMOUNT valve in aortic position
Download now
(230 KB)
‡ 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:
- Magna Ease valve Instructions for Use
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
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 2900 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 | Description | Size | Image |
|---|---|---|---|
| 2900 | Carpentier-Edwards PERIMOUNT pericardial aortic bioprosthesis |
19, 21, 23, 25, 27, and 29 mm |  |
| Model | Description | Compatible with Valve Models | Sizes |
|---|---|---|---|
| 1127-SET | Sizers - Complete Set | 2900 | Includes All |
| 1127 | Sizers - Individual | 2900 | 19, 21, 23, 25, 27, and 29 mm |
| TRAY1161 | Accessory Tray | 2900 | N/A |
| 1111 | Reusable Handle | 3300TFX, 3000, 2900 | N/A |
| 1126 | Longer Single-Use Handle | 3300TFX, 3000, 2900 | N/A |
Clinical summary:
Very long-term outcomes of the Carpentier-Edwards PERIMOUNT valve in aortic position
Download now
(230 KB)
‡ No clinical data are available that evaluate the long-term impact of the Edwards Lifesciences tissue treatments in patients.
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