St. Jude Medical Marks 25th Anniversary of First Mechanical Heart Valve Implant.

Business Editors & Health/Medical Writers

ST. PAUL, Minn.--(BUSINESS WIRE)--Oct. 3, 2002

St. Jude Medical, Inc. (NYSE:STJ) today celebrates the 25th anniversary of the Company's first mechanical heart valve implant, performed on October 3, 1977, at the University of Minnesota. Dr. Demetre Nicoloff implanted the valve in Helen Heikkinen from Angora, Minnesota, during a life-saving procedure at the University, where many other cardiac surgery milestones occurred.

Twenty-five years later, St. Jude Medical remains the world's undisputed leader in the mechanical heart valve market, with more than 1.3 million valves implanted in patients worldwide. The Company also offers a complete product line of heart valve replacement and repair products.

"St. Jude Medical's first bi-leaflet heart valve implant marked an important advance in cardiac surgery," said Robert Emery, M.D., of Cardiac Surgery Associates, Minneapolis and St. Paul, Minnesota, who participated in the 1977 surgery. "The valve's unique design offered significant benefits for patients, improving their quality of life and establishing new standards for performance and reliability."

The St. Jude Medical(R) mechanical heart valve, one of the most successful implanted devices ever brought to market, contributed to the Company's growth from a one-product, 12-employee business in 1977 to a $1.3 billion, almost 6,000-employee company today. In addition to heart valve replacement and repair products, St. Jude Medical now offers a broad portfolio of cardiovascular devices, including pacemakers, implantable cardioverter defibrillators (ICDs), specialty catheters, vascular closure devices, and sutureless connectors for heart bypass surgery.

The Company began to diversify in 1994 with several major acquisitions that broadened its product platforms and global infrastructure. Prior to 1994, St. Jude Medical's resources were focused on designing, improving and manufacturing the world's "gold standard" mechanical valves.

The initial design of the St. Jude Medical(R) mechanical heart valve resulted from a collaboration between Dr. Bhagavant Kalke, a surgical fellow at the University of Minnesota, and Dr. C. Walton Lillehei, the "father of open heart surgery," who led medical research at the University in the 1960s. Based on the configuration of irrigation dams from Dr. Kalke's native India, they developed a bi-leaflet mechanical valve design, which would open to allow blood to flow through, then immediately close to prevent it from backing up. This innovative concept, coupled with the use of pyrolytic carbon to produce the valve's components, produced the world's most technologically advanced mechanical heart valve.

Pyrolytic carbon is the world's hardest manufactured substance, contributing to the extraordinary strength and durability that have been a hallmark of the St. Jude Medical(R) mechanical heart valve. Initially, the Company depended on an outside supplier as its pyrolytic carbon source, but in 1991, the U.S. Food and Drug Administration (FDA) granted approval for the Company to produce its own pyrolytic carbon. Today, St. Jude Medical's(R) mechanical heart valve carbon components are manufactured at its Woodridge Carbon Technology Center, a 65,000 square foot state-of-the-art facility in St. Paul, Minnesota, the largest of its kind anywhere in the world.

It took eight years to implant the first 100,000 valves, four more to implant the second 100,000 and just 18 months to implant the next 100,000 valves. In 1990, St. Jude Medical implanted its 500,000th valve; in 1997 its 750,000th valve; and in 2000, the Company celebrated its one-millionth mechanical valve implant.

Since 1977, St. Jude Medical has refined and improved its mechanical heart valve products, although the fundamental design remains unchanged. The Company's newest mechanical valve, the SJM Regent(TM) aortic heart valve, received FDA approval in March 2002. Featuring subtle yet sophisticated design modifications to the valve's pyrolytic carbon components, the SJM Regent(TM) valve offers unprecedented hemodynamic performance, along with exceptional structural integrity, durability and low complication rates. The SJM Regent(TM) valve has been marketed in Europe and Canada since 1999.

"Today we celebrate an important milestone for St. Jude Medical, the University of Minnesota and our cardiac surgeon customers and their patients," said Terry L. Shepherd, Chairman and Chief Executive Officer of St. Jude Medical. "Our success in the heart valve business is largely due to the extraordinary collaboration we have enjoyed with leading cardiac surgeons and medical researchers around the world for 25 years. This trusted partnership has benefited the lives of more than one million patients, which is the truest benchmark of our success. Twenty-five years ago today, a surgical procedure saved a life, validated a company and contributed to the foundation of an important Minnesota industry."

The anniversary will be commemorated with events today at the University of Minnesota and St. Jude Medical's global headquarters in St. Paul, Minnesota. St. Jude Medical representatives will present a plaque to University of Minnesota officials and physicians at a ceremony at the University's Operating Room J, where the first implant occurred. At 12:30 p.m. CDT, the Company will host an employee event, featuring physicians affiliated with the University and the first implant, a St. Jude Medical valve recipient and Company officials. Kaye Lillehei, the wife of the late Dr. C. Walton Lillehei, will attend the event.

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, patient and payers unmatched clinical performance and demonstrated economic value.