Kensey Nash completes carotid pilot trial using its TriActiv ProGuard System in stenting

By Lisa Kerner

Erie, Pa., April 26 - Kensey Nash Corp. completed enrollment of a pilot trial for its TriActiv ProGuard Embolic Protection System in carotid stenting procedures.

The company said it will use the study data to submit a CE Mark application for use of the device during carotid stenting procedures, as well as for an Investigational Device Exemption submission to the Food and Drug Administration for a larger U.S. pivotal trial for the same indication.

The carotid pilot trial used Kensey Nash's newest version of the TriActiv System, incorporating Local Flush and eXtraction (LFX) technology for use in branched arteries.

The TriActiv ProGuard System, designed to reduce the incidence of embolic stroke during carotid stenting procedures, features a balloon protection guidewire, a flush catheter and an automated extraction system to remove debris.

"We are very pleased with the early experiences of our device in the carotid anatomy," president and chief executive officer Joe Kaufmann said in a company news release.

"During carotid stenting, it is imperative to provide the maximum protection against debris embolizing to the brain during the procedure. Competing filter devices, by design, cannot fully protect against microemboli, and for that reason we have confidence in our approach of balloon protection, flushing and automated extraction of any problematic debris."

Currently, the TriActiv System is indicated to prevent heart attacks during the treatment of saphenous vein grafts in patients who previously received coronary bypass surgery, but now have blockages in the grafts.

Kensey is a medical technology company based in Exton, Pa.

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