New Valve from St. Jude Approved
A new heart valve manufactured by St. Jude Medical, Incorporated, received marketing clearance from the Food and Drug Administration. The new device, the Epic Stented Tissue Valve, was created to reduce the possibility of tissue hardening secondary to calcification. The approval was described on the St. Jude website.
The device incorporated the St. Jude Medical Biocor technology for heart valves. In fact, the two devices utilize the same design. The Epic, however, includes anti-calcification technology to minimize tissue mineralization around the device. This should extend the life of the device for patients.
The Epic is available in mitral, aortic supra, and aortic models. The valve has a small profile; the lowest overall height of all available valves. This design simplifies the procedure for implanting the device. There are benefits noted with placement in both the aortic and mitral positions, reduction of aortic wall protrusion and minimal impedance of blood flow into the aorta, respectively.
Device durability is a key factor in deciding the most appropriate heart valve for patient implantation. Factors that influence the longevity of valves include tissue calcification and mechanical stress. Data collected over 17 years suggests that Bicor technology reduces mechanical stress. The benefit of such is reduced tissue fatigue.
Marketing for the device will commence in the beginning of next year.
November 30, 2007 Related topics: Product Approval & Certification, Cardiology