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Edwards to roll out Physio II

This article was originally published in The Gray Sheet

Executive Summary

Edwards Lifesciences will launch its Carpetier-Edwards Phyiso II mitral valve annuloplasty repair ring in the U.S. and Europe in the first quarter of 2009, and expects it to help drive a 15% revenue boost in its heart valve therapy division to nearly $670 million in 2009, the company announces during its Feb. 3 fourth-quarter earnings call. FDA recently cleared Physio II via 510(k) and the device also has CE mark approval. Physio II is the only annuloplasty ring to offer "shape optimization" that matches the shape of the ring to the shape of the patient's diseased valve, according to Edwards. It also features a unique sewing cuff, making it easier for surgeons to implant, according to the company

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