Edwards to restart heart valve study with new delivery system

By Angela McDaniels

Seattle, Dec. 1 - Edwards Lifesciences Corp. said it has received conditional approval from the U.S. Food and Drug Administration to enroll 20 patients in a non-randomized feasibility trial of its Cribier-Edwards percutaneous aortic heart valve.

Edwards enacted a voluntary suspension of a previous trial of the heart valve in June to incorporate a new retrograde delivery system.

The advanced retrograde delivery system provides a simpler route for introducing the valve non-surgically, threading it through the patient's circulatory system from the leg directly to their aortic valve, the company said.

The delivery system used in the previous study involved crossing the patient's septum and mitral valve to reach their native aortic valve and demonstrated a greater degree of clinical complexity and adverse outcomes than the retrograde approach.

The restarted trial, which will take place at three clinical sites, will use the new system and include an additional, larger 26 millimeter replacement heart valve.

Cases are expected to resume upon investigational review board approval and the completion of clinician training with the new delivery system, the company said.

"We are eager to resume this important trial, and are looking forward to treating the many patients who have been referred and qualify for this investigation," said William O'Neill, lead investigator and chief of cardiology at William Beaumont Hospital in Royal Oak, Mich., said in a company new release.

The new delivery system is also being introduced on a site-by-site basis in Europe, where a multi-center heart valve study has begun.

The Cribier-Edwards percutaneous aortic heart valve is a proprietary technology designed to treat patients with severe aortic heart valve stenosis, a narrowing of the valve that restricts blood flow, who are not good candidates for conventional open-heart valve replacement surgery.

Unlike conventional open-heart valve replacement surgery, percutaneous heart valve replacement can be performed without opening the chest and under local anesthesia, the company said.

The therapy was developed with Alain Cribier of the University Hospital in Rouen, France.

Based in Irvine, Calif., Edwards Lifesciences develops critical care technologies and products for the treatment of heart valve disease and peripheral vascular disease.

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