Kensey Nash achieves 3.2% MACE rate with embolic protection system

By Lisa Kerner

Erie, Pa., March 7 - Kensey Nash Corp. said it achieved a major adverse cardiac event (MACE) rate of 3.2% in its Aspire study of the effectiveness of the TriActiv FX Embolic Protection System to reduce MACE during the treatment of diseased saphenous vein grafts (SVG).

The TriActiv FX System is designed to prevent debris dislodged during stent procedures from embolizing and causing coronary events such as heart attacks, by gently flushing the treatment area within the vessel, according to a company news release.

The Aspire (Angioplasty in SVGs with Post Intervention Removal of Embolic Debris) study was a multi-center, prospective registry which enrolled more than 100 patients.

The rate of heart attacks in the Aspire study, included as part of the MACE rate, was 2.2%, a 67% reduction in the rate seen in the next best embolic protection device's data set, according to Kensey Nash. The company noted that procedure times were on average 15 minutes below the control cohort of the other embolic protection systems.

Kensey Nash said its system incorporates several ease-of-use design enhancements including a new balloon inflator that simplifies catheter exchanges and a new flush catheter design to reduce procedure time.

The use of embolic protection systems has helped reduce MACE rates in the SVG patient population to the 7% to 10% range (from 15% to 20%) in most previous studies, the company said.

"This is landmark data in the field of embolic protection," president and chief executive officer Joseph W. Kaufmann said in the release.

"This data has set a new standard supporting our belief that balloon protection provides the most effective means of preventing debris from migrating distally to the microvasculature, thus improving patient outcomes. We are very excited about the promise that the Aspire study holds for the future of embolic protection."

Kensey Nash submitted an application to the Food and Drug Administration for the TriActiv FX System in January. The company will highlight data from the Aspire study during the American College of Cardiology conference in Atlanta this month.

Kensey Nash's TriActiv ProGuard System is also in clinical studies to evaluate its performance in preventing strokes and other adverse events during carotid stenting procedures.

Kensey Nash, located in Exton, Pa., provides a range of medical technology products primarily in the endovascular, sports medicine and spine markets.

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