Embolic Protection During Carotid Stenting

The system includes three features designed to reduce the incidence of embolic stroke and increase protection during carotid stenting procedures: a balloon protection guidewire, a flush catheter, and an automated extraction system to remove debris. The system can be used in combination with any approved stent in the marketplace.

The ProGuard is the newest version of the TriActiv system product line, and is currently indicated to prevent heart attacks during the treatment of saphenous vein grafts (SVGs) in patients who previously received coronary bypass surgery but now have blockages in the grafts. The system has received the CE Mark for use during SVGs.

A pilot trial to study the safety of the ProGuard device in carotid stenting patients was held in early 2006 at five sites in the United States and Europe. The 50-patient study data showed no incidence of major strokes or death and is supporting a pending CE Mark application for use in carotid grafting. The company has also commenced enrollment of a 300-400 patient pivotal study that will take place at up to 35 U.S. and five European sites. The TriActiv ProGuard system is manufactured by Kensey Nash (Exton, PA, USA).

"As carotid stenting continues to be adopted, the effectiveness of embolic protection systems to prevent major adverse events (MAE) is paramount. The data from the TriActiv ProGuard pilot trial suggest that balloon protection in combination with gentle flushing and automated extraction is a promising solution,” said Rajesh Dave, M.D., chairman of endovascular medicine at Pinnacle Health Heart and Vascular Institute (Harrisburg, PA, USA), who will serve as co-principal investigator of the study.



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