STJ ST. Jude Medical, Inc.

St. Jude Medical, Inc. (NYSE:STJ) announced today the first implant of the SJM Biocor(R) stented tissue valve in the United States. The Company announced U.S. Food and Drug Administration (FDA) approval of the SJM Biocor(R) valve - its first stented tissue valve in the U.S. market - on August 8, 2005. The first U.S. implant of the device was performed on August 12, 2005, in a 72-year-old male patient by James R. Taylor, M.D., a cardiothoracic surgeon at St. Francis Hospital, the Heart Center, Roslyn, New York, a nationally recognized leader in cardiac care and cardiovascular surgery. "I was very pleased with Biocor's ease of implantability," said Dr. Taylor. "The FlexFit(TM) stent combined with the low post height to greatly ease placement of the valve, and the device's track record of durability internationally gives me confidence that the valve will continue to deliver excellent performance for many years to come." "This week's first implant of the SJM Biocor(R) valve marks the entry of St. Jude Medical into a critical segment of the U.S. market for heart valves--we couldn't be more pleased to be working with Dr. Taylor and St. Francis on this significant milestone," said George J. Fazio, President of St. Jude Medical's Cardiac Surgery Division. "St. Jude Medical and its family of heart valve replacement solutions have a track record of global leadership. I'm delighted that we can now offer this clinically-proven stented tissue prosthesis to our U.S. physicians and their patients." Clinical experience with the SJM Biocor(R) family of stented tissue valves has reached 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 documents the SJM Biocor(R) valve's excellent durability in both the aortic and more challenging mitral positions. 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 being introduced to the U.S. market during the third quarter of 2005. These product introductions enable St. Jude Medical to provide the industry's most complete portfolio of heart valve replacement and repair solutions. St. Jude Medical, Inc. (www.sjm.com) is dedicated to the design, manufacture and distribution of innovative medical devices of the highest quality, offering physicians, patients and payers outstanding clinical performance and demonstrated economic value. Any statements made regarding the Company's anticipated future product launches, regulatory approvals, revenues, earnings, market shares, and potential clinical success are forward-looking statements which are subject to risks and uncertainties, such as those described in the Financial Section of the Company's Annual Report to Shareholders for the fiscal year ended December 31, 2004 (see page 16). Actual results may differ materially from anticipated results.