Porcine Tissue Valve Cleared by FDA

A porcine stentless bioprosthesis has been cleared by the U.S. Food and Drug Administration (FDA). The tissue valve is intended for surgeons who prefer a stentless alternative for replacing a patient's diseased or malfunctioning aortic heart valve.

Surgeons can choose to replace an affected valve with either a bioprosthetic valve, generally made of animal tissue, or a prosthetic mechanical valve, made of metal and carbon. A key advantage of tissue valves is that patients do not have to take blood-thinning agents on a long-term basis, as they do with mechanical valves. Because of this advantage and their quality-of-life benefits, tissue valves are increasingly being used more than mechanical valves.

The new valve, called Edwards Prima Plus, is the product of Edwards Life Sciences Corp. (Irvine, CA). The valve is part of the company's family of cardiac surgery products. "The Edwards Prima Plus has the advantage of our proprietary XenoLogix tissue treatment and offers a range of features designed to ease surgical implantation, which differentiate this valve from other stentless products,” noted Michael A. Mussallem, chairman and CEO of Edwards.



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