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FDA OKs Edwards' Perimount Magna heart valve:

This article was originally published in Clinica

Executive Summary

The US FDA has approved for sale Edwards Lifesciences' Carpentier-Edwards Perimount Magna tissue heart valve for replacing diseased or defective valves. The aortic pericardial bioprosthesis is specifically designed to optimise blood flow for the patient, said the Irvine, California firm. In addition, it is configured to facilitate placement above the patient's native annulus, and its streamlined sewing ring maximises the valve size that can be implanted. It is also treated with Edwards' proprietary XenoLogiX tissue treatment, which removes phospholipids from the bovine pericardial tissue. The product will be released in a limited capacity during the current quarter, followed by a full-scale launch in 2004. Edwards estimates the heart valve repair and replacement market to be worth $900m.

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