Medical Manufacturer Gets FDA Approval for Heart Valve

April 20, 2011
Each year, approximately 90,000 patients in the U.S. undergo open-heart surgery to replace their diseased, damaged heart valves.

St. Jude Medical, Inc., a global medical device company, announced on April 20 that it has received U.S. FDA approval for its Trifecta valve. The valve, a clinically-proven replacement for diseased, damaged or malfunctioning aortic heart valves, mimics the flow of a natural, healthy heart.

"The Trifecta valve will continue the ongoing transformation of stented aortic valve replacement," said Joseph E. Bavaria, M.D., Roberts-Measy director and vice chief of cardiovascular surgery at the University of Pennsylvania in Philadelphia, Pa. "While each new technology that extends the portfolio of tissue valve solutions for physicians is critical for enhanced patient care, the Trifecta valve is a significant step forward for cardiac surgeons in the United States. The valve is already becoming known for its exceptional hemodynamic performance, one factor that is particularly important for the treatment of patients with diseased aortic heart valves."

To ensure the structural integrity of the valve, the Trifecta valve is constructed using a polyester and tissue-covered titanium stent, or base, the company said. The valve features leaflets manufactured from pericardial tissue attached to the exterior of the valve stent. This design allows the leaflets to open more fully and efficiently, mimicking the performance of a healthy aortic heart valve and limiting tissue abrasion through tissue-to-tissue (stent-to-leaflet) contact. Also contributing to the valve's durability, the valve offers the St. Jude Medical patented Linx AC Technology, an anticalcification treatment designed to reduce tissue mineralization (hardening), one of the primary causes of valve deterioration.

Each year, approximately 90,000 patients in the U.S. undergo open-heart surgery to replace their diseased, damaged heart valves.

The Trifecta valve was approved by regulatory authorities in Europe and Canada in 2010.

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