TriActive trials
This article was originally published in The Gray Sheet
Executive Summary
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...