AGA Medical Holdings, Inc.
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Latest From AGA Medical Holdings, Inc.
News Briefs: FDA Turns Down Wright’s Augment; Cook Resumes Zilver PTX Shipments; Luminex Restructures
Wright Medical receives not approvable letter for its Augment bone graft asking for another study. Judge rules against Zimmer in favor of Strkyer in patent case. Cook Medical has resolved the problems that triggered a December 2012 recall of its Zilver PTX peripheral stent. Luminex cuts staff, invests in molecular diagnostics efforts.
More study is required to make sense of the adverse event rates associated with two marketed atrial septal defect occluders, a May 24 FDA panel concluded. St. Jude Medical, in particular, should start a new prospective study for its Amplatzer device, the panel recommends.
Transcatheter LAA closure devices are starting to amass the level of data required to demonstrate their safety and effectiveness, and, if all goes well, the long-awaited FDA approval of the first such device – Boston Scientific’s Watchman – could finally occur sometme next year. Although LAA closure devices have already taken off in some European countries, US physicians continue to struggle with lingering uncertainties, about the learning curve, procedural safety and how LAA closure will stack up against newer anticoagulant drugs. Regardless of how these issues are eventually resolved, industry leaders see a big opportunity for a successful device in the LAA closure space, with market estimates of $1 billion considered conservative by some.
Endovascular aortic aneurysm repair procedures account for the majority of abdominal aortic aneurysm repairs performed in the US, and total worldwide revenues from aortic endograft systems now exceed $1 billion per year. Many believe that continuing improvements in endograft technology will drive EVAR penetration to 90% or beyond within the next five to 10 years. This article first appeared in the April issue of Medtech Insight, April 2011.