St. Jude Medical Receives Approvals for Three New Heart Valve Products

St. Jude Medical Inc. announced regulatory approvals of three new heart valve replacement and repair products. Those approvals include CE Marking of the SJM Epic valve, FDA 510-K clearance and CE Marking of the SJM Tailor annuloplasty ring, and FDA 510-K clearance of the SJM Pericardial Patch with EnCap technology.

The SJM Epic product is a new stented porcine valve that incorporates the company's proprietary Linx antimineralization technology designed to mitigate calcification of the valve leaflets. European market release is planned for early 1999.

The SJM Tailor annuloplasty ring is a fully flexible ring for those procedures where a clinician chooses to repair versus replace a mitral or tricuspid heart valve. The product will be launched over the next few months in both the U.S. and Europe.

The SJM Pericardial Patch with EnCap technology is a piece of bovine pericardium tissue used during cardiac surgery for great vessel reconstruction and repair and pericardial closure. The product will be launched this quarter in the U.S. The patch is manufactured by Glycar, Inc. and distributed exclusively by the St. Jude Medical Heart Valve Division worldwide.