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Edwards’ percutaneous valve

This article was originally published in The Gray Sheet

Executive Summary

Edwards Lifesciences' "single largest investment increase" in the near term is to accelerate the European launch of its Sapien transcatheter heart valve, says CEO Michael Mussallem July 23 during the firm's 2007 second quarter earnings call. Edwards anticipates gaining CE mark for the device in time for year-end introduction. Competitor CoreValve (ReValving) got European approval in May. Edwards hopes to launch Sapien in the United States by 2010 (1"The Gray Sheet" March 26, 2007, p. 10). The company is also reinforcing its U.S. heart valve sales force in anticipation of FDA-approval of the Magna mitral tissue valve this year. But with timing of the Magna approval uncertain, the company is advising that its full year 2007 revenues will be on the low end of previous guidance of $1.07 billion to $1.11 billion, with heart valve sales in the second half of 2007 between $250 million and $260 million...
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