Medical Device Market & Industry Briefs, August 2012
Executive Summary
Brief summaries of recent medtech market and industry developments. This month we cover continuing pressures on the DES and ICD markets, update Edwards’ efforts to roll out its Sapien device for TAVR, and report on QLT’s decision to sell its punctal plug technology.
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Everything-But-CRM Growth Drivers Slow In Q2 For St. Jude
Amid a persistently contracting cardiac rhythm management market, the firm’s CRM business, while not growing, performed better than expected in the second quarter. But several of it its non-CRM businesses, which the company relies on to drive growth, experienced a slowdown.
Sapien Heart Valve Gets FDA Panel Nod For High-Risk Surgical Patients
Edwards Lifesciences’ first-to-market transcatheter valve is safe and effective, and its benefits outweigh its risks in an expanded patient population, an FDA advisory panel says.
CMS Policy Sets Boundaries On Transcatheter Valve Procedure
New Medicare coverage policy for transcatheter aortic valve replacement is a significant step for the nascent procedure and a possible window into how the agency will address future high-profile, early-stage technologies.