FDA APPROVES ST. JUDE'S BIOCOR STENTED TISSUE VALVES
St. Jude Medical's SJM Biocor and Biocor Supra family of stented tissue valves -- the company's first stented tissue valves in the U.S. market -- have been approved by the FDA and are expected to be introduced during the third quarter of this year.
The SJM Biocor and Biocor Supra valves offer the FlexFit stent, made up of a flexible co-polymer material that provides easy conformation to the annulus. The company also said the valves feature low anatomic profile (height), minimizing aortic wall protrusion and left ventricular outflow tract obstruction in the mitral position.
In addition to the SJM Biocor aortic and mitral models, St. Jude has also received FDA approval for the SJM Biocor Supra stented tissue aortic valve, a supraannular valve implanted above the annulus, which is the supporting structure at the base of each aortic valve leaflet. The SJM Biocor Supra valve optimizes the orifice-to-annulus ratio for valves implanted in the small aortic root.