April 11, 2007 — Kensey Nash Corp. has announced it has received CE Mark approval to expand the indication for the third generation of its embolic protection technology, known as the TriActiv ProGuard System, for use in the carotid anatomy.
The new indication is significant for the Kensey Nash device in the European marketplace because the use of embolic protection devices is very prominent in carotid stenting procedures. The company had launched the TriActiv ProGuard System in Europe for use in saphenous vein graft procedures last year.
The product line incorporates Local Flush and eXtraction (LFX(TM)) technology designed for use in branched anatomy, such as those of the carotid arteries. The TriActiv ProGuard System incorporates three features designed to reduce the incidence of embolic stroke during carotid stenting procedures — a balloon protection guide wire, a flush catheter, and an automated extraction system to remove debris. The system has been clinically studied and can be used in combination with any approved carotid stent in the marketplace.
To support the CE Mark, Kensey Nash had completed a pilot trial to study the safety of the TriActiv ProGuard device in carotid patients at 5 sites in the U.S. and Europe.
A 50-patient pilot trial at five U.S. European sites supports the CE mark and studied the device’s safety. The data showed no incidence of major strokes or death. Kensey Nash is also currently enrolling patients in the PROGUARD Carotid Pivotal Study, a 300-400 patient registry, the results of which are intended to support FDA clearance.
For more information visit www.kenseynash.com.