FDA grants St. Jude approval for Trifecta valve
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.
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.