Mathematically modeled, bioengineered design
Optimized for hemodynamics, durability and implantability
Content relating to Edwards Lifesciences devices is intended for healthcare professionals.
Carpentier-Edwards PERIMOUNT Magna Ease aortic valve
Built upon the Carpentier-Edwards PERIMOUNT bioprosthesis design.
A first in design, with a history of demonstrated performance
The Carpentier-Edwards PERIMOUNT Magna Ease aortic valve is part of the proven family of PERIMOUNT surgical valves.
Backed by over 20 years of published clinical studies for proven longevity and demonstrated hemodynamic stability, the Carpentier-Edwards PERIMOUNT Magna Ease aortic valve combines a tested design with the benefits of pericardial tissue to deliver the potential for on-going durability.
Proven PERIMOUNT valve design
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
After more than 1 billion cycles, the Magna Ease valve still performed like new14
The Magna Ease valves demonstrated excellent durability after the equivalent of 25 years in simulated in vitro wear, with hydrodynamic performance similar to that of a new valve.
Clinical studies show excellent long-term durability
More long-term clinical study publications than any other bioprosthetic aortic valve.
Actuarial freedom from structural valve deterioration
* Freedom from explant/prosthesis replacement/reoperation due to SVD
Ease of implant
The PERIMOUNT Magna Ease valve offers many key design features that enhance the valve’s ease of implant.
*No clinical data are available that evaluate the long-term impact of the Carpentier-Edwards ThermaFix issue process in patients
Demonstrated hemodynamic performance
Excellent EOAs and low gradients based on the proven PERIMOUNT valve design.15
Specifications
Indications
The Carpentier-Edwards PERIMOUNT Magna Ease pericardial 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: Glutaraldehyde
- Rinse procedure: 500 ml (sterile physiological saline solution) x 60 seconds. Repeat once using new saline solution.
*No clinical data are available that evaluate the long-term impact of the Carpentier-Edwards ThermaFix issue process in patients
Clinical communiqué
20 year results Carpentier- Edwards PERIMOUNT pericardial aortic bioprosthesis.
