St. Jude Medical to Showcase Leading Tissue Valves and Heart Bypass Connectors At Meeting of...

Business Editors & Health/Medical Writers

ST. PAUL, Minn.--(BUSINESS WIRE)--Sept. 20, 2002

St. Jude Medical, Inc. (NYSE:STJ) will begin the European launch of its newest tissue valve and present clinical data on its family of sutureless coronary bypass connectors at the 16th

The Company will initiate the European full market launch of its Toronto Root(TM) tissue valve, a stentless bioprosthesis used in procedures where aortic root and valve replacement are indicated. This valve combines the proven advantages of St. Jude Medical's leading Toronto SPV(R) valve with its proprietary BiLinx(TM) anticalcification technology. BiLinx(TM) is the only technology designed to reduce calcification on both the aortic wall tissue and the aortic leaflets.

"The Toronto Root(TM) valve provides significant benefits with its BiLinx(TM) anticalcification technology, which may extend the valve's durability because of its unique anticalcification properties," said Professor Friedrich Mohr, Chief of Cardiothoracic Surgery, University of Leipzig, Leipzig, Germany. "The potential to prevent calcification on the aortic wall as well as the leaflets may allow us to use this valve in younger patients," Mohr continued. "The Toronto Root(TM) valve also offers superior tissue handling characteristics, providing more flexibility and better suture retention than other tissue valves."

The Toronto Root(TM) valve is currently undergoing clinical studies in the United States and Canada.

Four presentations at EACTS and its Techno-College seminar will highlight clinical experience with St. Jude Medical's Symmetry(TM) Bypass System sutureless anastomotic devices. These products are the first mechanical connectors for coronary artery bypass grafting (CABG) procedures, eliminating the need for sutures or aortic clamps, while offering a fast, reproducible method to create the bypass anastomosis (connection).

The first of these products--the Symmetry(TM) Bypass System Aortic Connector--allows cardiac surgeons to attach vein grafts to the aorta without sutures, facilitating a clampless aortic anastomosis. Reducing aortic manipulation may decrease the neurological risks associated with bypass surgery, such as memory loss, problems with fine motor skills, and strokes.

Sven Martens, M.D., from the JWGoethe University Hospital, Frankfurt, Germany, will present data from a prospective randomized trial comparing CABG procedures using the Symmetry(TM) Bypass System Aortic Connector with those using traditional suturing methods. His study showed that 96.8 percent of the bypass grafts using the Aortic Connector were patent (open) immediately following surgery. At 8.3 months postoperative, no patients in the connector group required re-interventions (additional procedures related to the original bypass operation).

Stephen Clark, a cardiothoracic surgeon at Freeman Hospital, Newcastle upon Tyne, United Kingdom, will highlight his clinical experience with the Aortic Connector. A total of 102 connectors were deployed in 41 patients undergoing bypass surgery with a heart-lung machine ("on-pump"). The results showed a 31 percent reduction in surgical time for patients who had the Aortic Connector, compared with a matched group undergoing conventional suturing. Studies have shown adverse side effects for patients connected to heart-lung machines, which increase in proportion to the time that patients must remain on-pump.

Massimo Lemma, M.D., a cardiac surgeon at Luigi Sacco Hospital, Milano, Italy, will present results of his initial clinical experience using 60 Aortic Connector devices in 51 patients. Following surgery, angiography was performed on 48 of the patients, which showed a patency rate of 96.4 percent. One-year later, follow-up angiography in 9 patients showed a patency rate of 100 percent. Dr. Lemma notes that the device is particularly useful in off-pump procedures.

Kenton Zehr, M.D., Associate Professor of Surgery, Mayo Clinic, Rochester, Minnesota, will review results of an animal study using St. Jude Medical's stainless steel clip system for small vessels used to attach saphenous vein grafts to the heart's coronary arteries. Following surgery, all the bypass grafts were patent at 30, 90 and 180 days. The study concluded that using a sutureless small vessel connector is feasible, rapid and reproducible with both on- and off-pump bypass procedures. It noted that these types of technologies might become important tools for surgeons, particularly in off-pump or minimally invasive CABG surgery. St. Jude Medical's small vessel connector is currently in human clinical trials in Europe.

Any statements made regarding St. Jude Medical's anticipated future product launches, 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, 2001 (page 4-6). Actual results may differ materially from anticipated results.

St. Jude Medical, Inc. (www.sjm.com) is dedicated to the design, manufacture and distribution of innovative medial devices of the highest quality, offering physicians, patients and payers unmatched clinical performance and demonstrated economic value.