FDA grants St. Jude approval for Trifecta valve

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The FDA has granted St. Jude Medical approval for its Trifecta valve, a pericardial aortic tissue valve used in the replacement of diseased, damaged or malfunctioning aortic heart valves.

St. Paul, Minn.-based St. Jude said that the Trifecta valve optimizes blood flow and produces long-term durability and is constructed using a polyester and tissue-covered titanium stent.

The valve also has leaflets from pericardial tissue that are attached to the exterior of the valve’s stent, which mimic a healthy aortic heart valve and limit tissue abrasion through stent-to-leaflet contact.

St. Jude said that the device makes implantation easier and gives physicians more control. The valve was approved for use in Europe and Canada in 2010.