St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, announced that its Trifecta™ biological pericardial aortic valve has demonstrated positive results in a new study published online in The Journal of Thoracic and Cardiovascular Surgery. The Trifecta valve was evaluated in patients who required aortic valve replacement surgery. The results highlight the outstanding hemodynamic performance of the Trifecta valve (the ability to maximize blood flow through the valve), further confirm safety, and describe its ease of use. This study is one of the largest, multi-center, prospective studies ever conducted on a surgical aortic heart valve.
Conducted at 31 medical centers in the U.S., Canada and Europe, the study followed 1,014 eligible patients implanted with the Trifecta valve between 2007 and 2009 as part of a U.S. Food and Drug Administration (FDA) pre-market approval study. Data from the study was used to secure European CE Mark approval in 2010, FDA approval in 2011 as well as regulatory approval of the Trifecta valve in Japan in 2012.
A three leaflet tissue valve constructed from a polyester and tissue-covered titanium stent, the Trifecta valve serves as a replacement for the aortic valve, which is located between the heart's left ventricle and the aorta (the vessel which carries blood from the heart to the rest of the body). The valve features leaflets made of pericardial tissue that are attached to the exterior of the stent. This design allows the leaflets to open more fully and efficiently, mimicking the hemodynamic performance of a healthy aortic heart valve. It also limits tissue abrasion through tissue-to-tissue (stent-to-leaflet) contact, which helps protect the valve against mechanical wear. A polyester sewing cuff connects the valve to the annulus of the aortic valve. Finally, the valve also features Linx ™ AC Technology, an anti-calcification treatment designed to reduce tissue mineralization (hardening), which can lead to valve deterioration over time.
Dr. Joseph E. Bavaria, Roberts-Measey endowed professor and vice-chief of cardiovascular surgery at the University of Pennsylvania, served as lead author of the journal article.
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