St. Jude Medical’s Epic Stented Tissue Valve with Anti-Calcification Technology Receives FDA Approval


November 27, 2007

November 27, 2007 - St. Jude Medical Inc. announced FDA approval of its Epic Stented Tissue Valve with Linx AC Technology. The Epic Valve, which is identical in design to the company’s Biocor Valve, also incorporates patented anti-calcification technology designed to protect against tissue mineralization, or hardening.

An estimated 100,000 Americans undergo heart valve replacement annually and the majority of them receive tissue valves. Valve durability is affected by both mechanical stress and tissue calcification. The Epic Valve is designed to address both issues to deliver long-term performance.

"The Epic Valve sets a new standard for addressing tissue mineralization and potentially extending long-term valve durability," said Vibhu Kshettry, M.D., director of Cardiac Surgery at the Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis, and a principal investigator in the Epic clinical study. "Enhanced durability, combined with a design that facilitates the implant procedure, makes the Epic Valve an ideal prosthesis."

The Epic Valve reportedly features the industry's lowest overall valve height, enhancing implantability. In the mitral position, the valve's low profile reduces the risk of obstructing blood flow into the aorta. In the aortic position, it may provide optimal coronary ostia clearance and reduce the risk of aortic wall protrusion. The new valve will be available in aortic, aortic supra and mitral models.

St. Jude Medical plans to roll out the Epic Valve beginning early 2008.

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