Percutaneous Heart Valves May Demand Novel Regulatory Approach
This article was originally published in The Gray Sheet
Executive Summary
Leading innovators hope to blaze a trail through what some see as formidable regulatory barriers to technological advances allowing diseased aortic valves to be replaced percutaneously
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People In Brief
Stentys adds regulatory exec: Paris-based start-up signals its intention to take the next steps in development of its coronary bifurcation lesion drug-eluting stent with the Feb. 21 appointment of Luc Morisset as director of regulatory affairs. Stentys plans to start feasibility studies by mid-year. Its technology allows a stent to open to a side branch vessel without relying on accurate positioning by the clinician, according to the firm. Morisset spent the last decade as director of regulatory affairs for MedPass International, a European medtech consulting firm. He also worked more than five years at the French Ministry of Health where he was involved in medical device approvals. Morisset joins CEO Gonzague Issenmann, who co-founded the firm in 2005 after leaving his position as finance controller for Johnson & Johnson/Cordis' European unit. Stentys co-founder and "non-executive" president Jacques Séguin is also currently CEO of Irvine, Calif.-based CoreValve, which is developing the ReValving system for percutaneous aortic valve replacement (1"The Gray Sheet" Oct. 30, 2006, p. 9)...