Kensey Nash Exits Embolic Protection To Focus R&D Cash On Biomaterials
This article was originally published in The Gray Sheet
Executive Summary
Kensey Nash's discontinuation of its embolic protection device business will free-up R&D resources for its biomaterials division, the firm says
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Kensey Nash initiates pivotal trial enrollment for the ProGuard update to its TriActive embolic protection system in carotid stenting procedures. The Exton, Pa. firm hopes to complete the 300- to 400-patient multicenter trial to support a 510(k) submission by early 2008. The device is designed to reduce incidence of embolic stroke during carotid artery angioplasty using a balloon protection guidewire, flush catheter and an automated extraction system to remove debris. Kensey Nash says the ProGuard can be used in combination with any currently marketed carotid stent. A pilot trial, completed earlier this year, found no incidence of major stroke or death in 50 patients...
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