FDA approves St. Jude Medical's Trifecta valve for stented aortic valve replacement

St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced that it has received U.S. Food and Drug Administration (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 and represents a significant new product in the pericardial aortic stented tissue valve market.

“The Trifecta valve will continue the ongoing transformation of stented aortic valve replacement”

"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."

Building upon more than 30 years of St. Jude Medical experience in developing heart valves, the Trifecta valve was designed for excellent hemodynamic performance (the optimization of blood flow through the valve) and long-term durability. To ensure the structural integrity of the valve, the Trifecta valve is constructed using a polyester and tissue-covered titanium stent, or base. 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 Trifecta 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.

The Trifecta valve offers several features that improve the ease of implantation, including the valve's unique holder, designed to improve visibility and cuff access for suturing, and customized sizer, offering physicians more control in choosing the appropriate replacement valve for each patient's heart.

"Physicians around the world have already voiced tremendous excitement and satisfaction with the Trifecta valve," said Frank J. Callaghan, president of the St. Jude Medical Cardiovascular Division. "Trifecta has demonstrated outstanding hemodynamic performance and has improved the lives of patients with aortic valve disease. We are proud to continue our legacy of market-leading valves with this advanced technology and will strive to continue advancing valve solutions for physicians and patients around the world."

Each year, approximately 90,000 patients in the U.S. undergo open-heart surgery to replace their diseased, damaged heart valves. The Trifecta stented tissue valve further expands the St. Jude Medical valve product portfolio, which includes market-leading mechanical heart valves, valve annuloplasty rings and porcine tissue valves with superior durability for both the aortic and mitral valve.

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