New Surgical Valve Receives CE Mark Approval

March 2, 2010 — A surgical valve has earned the European market clearance nod, marking the manufacturer's launch into the market for pericardial aortic stented tissue valves.

The Trifecta tissue valve is used to replace a patient’s diseased, damaged or malfunctioning aortic heart valve, which controls blood flow from the heart to the rest of the body.

The next-generation tissue valve has a trileaflet stented pericardial design which offers excellent hemodynamic performance, or nearly unobstructed blood flow, in order to mimic as closely as possible the flow of a natural, healthy heart. The unique valve design includes leaflets manufactured from pericardial tissue attached to the exterior of the valve stent which open more fully and efficiently to perform like a natural heart valve.

The valve’s titanium stent, which provides a fatigue resistant frame to support the valve within a patient’s heart, is covered with pericardial tissue to allow tissue-to-tissue contact when the leaflets open and close, which reduces the amount of wear and deterioration. Additional attributes contributing to the Trifecta valve’s durability include proprietary tissue fixation and St. Jude Medical’s patented Linx AC Technology, an anticalcification treatment designed to reduce tissue mineralization (hardening).

“The Trifecta valve’s superior hemodynamic performance helps to make it very attractive for aortic valve replacement, especially in a small aortic annulus”, said professor Volkmar Falk, chair of the division of cardiac and vascular surgery at University Hospital Zurich. “The construction and design of the Trifecta valve allows it to work seamlessly with the patient’s heart to generate adequate blood flow, which can offer patients an improved quality of life.”

With nearly 3.4 million patients in Europe suffering from aortic stenosis, the Trifecta valve is available in a wide range of sizes to offer physicians more control in choosing the appropriate replacement valve for each patient’s heart. The Trifecta stented tissue valve further expands St. Jude Medical’s valve product portfolio which includes mechanical heart valves, valve annuloplasty rings and porcine tissue valves for both the aortic and mitral valve.

Trifecta has been specifically designed for improved hemodynamics, durability and implantability.

For more information: www.sjm.com