Bovine Heart Valve Cleared by FDA

A bovine periocardial tissue heart valve designed specifically for the mitral position has been cleared by the U.S. Food and Drug Administration (FDA). Called the mitral Perimount Pericardial Bioprosthesis, the valve is the product of Edwards Lifesciences (Irvine, CA, USA).

Edwards introduced the Perimount valve for aortic patients almost a decade ago and now provides the mitral counterpart. According to the company, tissue valves are increasingly being chosen by doctors and their patients over mechanical valves. Patients with tissue valves do not have to have long-term treatment with blood thinning agents, a big advantage.

The Perimount was developed by Dr. Alain Carpentier, chairman of the department of cardiovascular surgery at the Hopital Europeen Georges Pompidou in Paris (France), working with bioengineers at Edwards LifeSciences. The development involved Edwards' proprietary tissue preservation process, a resilient wireframe stent optimally designed using computer-aided 3-D modeling techniques, patented technology for tissue selection, and integrated manufacturing processes that make the valve robust and able to withstand the increased pressures of the mitral position.

We've been looking forward to having this valve in our repertoire for a number of years, and it is finally here, said Dr. Delos M. Cosgrove, chairman of the department of thoracic and cardiovascular surgery at The Cleveland Clinic Foundation (OH, USA).



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