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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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TriActive trials

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...

Warning Letter Roundup & Recap – 8 April 2020

Manufacturers of endoscopic equipment, biofeedback devices and thermometers were among those cited for regulatory violations in US FDA warning letters this week. A total of four device-related enforcement missives were released by the agency.




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