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FDA approves Edwards' porcine replacement heart valve:

This article was originally published in Clinica

Executive Summary

The US FDA has approved Edwards Lifesciences' Carpentier-Edwards SAV porcine replacement heart valve, which the firm says has a 20-year history outside of the US. The bioprosthesis allows for supra-annular implantation - above a patient's native aortic valve, rather than directly into the aortic annulus - and a proprietary scalloped sewing band for optimising anatomic fit. Supra-annular placement allows surgeons to implant a larger-orifice valve, which provides improved haemodynamic performance over intra-annularly placed porcine aortic heart valves, explains the Irvine, California firm. The valve also features Edwards' XenoLogiX tissue treatment.

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