St. Jude Enters Stent Market

St. Paul, MN - St. Jude Medical, Inc. announced it has received U.S. Food and Drug Administration (FDA) approval for the SJM Biocor and Biocor Supra family of stented tissue valves, the Company's first stented tissue valves in the U.S. market.

The approval will allow St. Jude Medical, long known for its leadership in mechanical heart valves, to bring its expertise to the U.S. stented tissue valve segment, which currently represents 60% of the U.S. market for heart valves.

"Today's announcement marks a significant milestone as St. Jude Medical adds to its expanding portfolio of tissue valves and other innovative technologies for cardiac surgeons and their patients," said George J. Fazio, President of St. Jude Medical's Cardiac Surgery Division. "The SJM Biocor(R) valve has a well-established track record around the world of outstanding clinical performance in both the aortic and mitral valve positions. We look forward to bringing our expertise to this important segment of the U.S. heart valve market and to offering this clinically-proven product to our U.S. customers."

The SJM Biocor(R) and Biocor(R) Supra valves offer several unique ease-of-implant characteristics. The FlexFit(TM) stent, constructed of a flexible co-polymer material, provides easy conformation to the annulus. The valve also features the lowest anatomic profile (height) in the U.S. tissue valve market, minimizing aortic wall protrusion and left ventricular outflow tract obstruction in the mitral position.

Clinical experience with the SJM Biocor(R) family of stented tissue valves is approaching 20 years. The peer-reviewed article "Seventeen-Year Experience with the St. Jude Medical Biocor Porcine Bioprosthesis" by Dr. Pia Myken of Sahlgrenska University Hospital, Gothenburg, Sweden, was published in the July 2005 issue of the Journal of Heart Valve Disease. The article demonstrates the SJM Biocor(R) valve's excellent durability in both the aortic and more challenging mitral positions. In an interview commenting on her extensive clinical experience with the Biocor valve, Dr. Myken said, "This is a valve we have used for 20 years, mainly for its durability. We have not found any reason to change (bioprosthesis)."

In addition to the SJM Biocor(R) aortic and mitral models, the Company has also received FDA approval for the SJM Biocor(R) 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(R) Supra valve optimizes the orifice-to-annulus ratio for valves implanted in the small aortic root.

Both the SJM Biocor(R) valve and the SJM Biocor(R) Supra valve are expected to be introduced during the third quarter of 2005.

SOURCE: St. Jude Medical, Inc.