Clinical Results of St. Jude Medical Symmetry Bypass System Coronary Connector and AF Suppression Algorithm to be Presented at American Heart Association Meeting.

Business Editors & Health/Medical Writers

ST. PAUL, Minn.--(BUSINESS WIRE)--Nov. 8, 2001

St. Jude Medical Receives European CE Marking for First Model of

Coronary Connector Product Line

Leading physicians will present clinical data on two technologies available only from St. Jude Medical at the American Heart Association (AHA) Scientific Sessions to be held November 11-14 in Anaheim, California. These studies feature the St. Jude Medical Symmetry(TM) Bypass System Coronary (or "Distal") Connector, a sutureless mechanical connector used for coronary artery bypass graft (CABG) surgery, and the St. Jude Medical AF Suppression(TM) algorithm, a pacing technology clinically demonstrated to reduce atrial fibrillation (AF) episodes in pacemaker patients suffering from AF - the world's most common cardiac arrhythmia.

Professor Thierry Carrel, Professor of Surgery and Chairman at University Hospital, Berne, Switzerland, will present initial clinical results of St. Jude Medical's Symmetry(TM) Bypass System Coronary Connector, the newest in a line of St. Jude Medical connector technologies. This first coronary, or distal, connector mechanically connects saphenous vein grafts to coronary arteries during CABG procedures. St. Jude Medical recently received CE Marking for this first-generation connector for use in small vessels.

Professor Carrel will review and discuss the early clinical experience with St. Jude Medical's Coronary Connector technology on Monday, November 12, at 11:00 a.m. PST. Initial results showed that the Coronary Connector provided consistently uniform anastomoses with instantaneous hemostasis in significantly less time than hand-sewn techniques, with each connector deployment taking less than two minutes.

St. Jude Medical is the worldwide leader in developing and marketing mechanical connectors and delivery systems to address the CABG market. In May 2001, St. Jude Medical received U.S. Food and Drug Administration (FDA) clearance for the Aortic Connector that connects the vein graft to the aorta. Over 5000 implants at over 150 U.S. open-heart centers have occurred since that regulatory milestone. The small caliber Connector discussed by Professor Carrel is the next step in St. Jude Medical's development of anastomotic technologies that will eventually connect all grafts to the heart and other locations.

More than 750,000 coronary artery bypass graft procedures are performed annually worldwide, requiring multiple connections (anastomoses) between the vein grafts and the aorta (proximal connection) and coronary arteries (distal or coronary connection) of the heart. In CABG surgery, the anastomosis, or the suturing of the graft to the aorta and the coronary artery, is usually the most difficult, time-consuming and critical part of the bypass procedure. Symmetry(TM) Bypass System connectors allow a cardiac surgeon to make these anastomoses without sutures.

Commenting on the clinical results to be presented at AHA and the CE Marking for the Coronary Connector, Steven J. Healy, President of the St. Jude Medical Cardiac Surgery Division, said, "We believe clinicians will react very positively to this initial study of the Coronary Connector. Clinician interest in our Aortic Connector product, now available in both the U.S. and Europe, has exceeded our expectations. The recent CE Marking approval in Europe of the first model in our small caliber Connector product line is an important milestone for St. Jude Medical in our commitment to bring to market an innovative and comprehensive approach to coronary artery bypass surgery. We plan to develop other configurations of the coronary product, based on feedback from surgeons, and look forward to submitting a new Symmetry(TM) Bypass product to the FDA for review in 2002."

CE Marking approval of this model of the Connector product triggers a $5 million milestone payment to the former shareholders of Vascular Science, Inc. This $5 million payment will be expensed as purchased in-process research and development in St. Jude Medical's results for the quarter ending December 31, 2001.

The second study at AHA focuses on St. Jude Medical's AF Suppression(TM) technology. It will be presented by Dr. Mark David Carlson M.D., M.A., Vice Chairman, Department of Medicine, University Hospitals of Cleveland, and reviews promising data supporting the efficacy of the Company's AF Suppression(TM) algorithm. Dr. Carlson will present additional results from the Atrial Dynamic Overdrive Pacing Trial-A (ADOPT-A) study, reviewing the AF Suppression(TM) algorithm's impact on patients with organized atrial tachyarrhythmias. The presentation is on Monday, Nov. 12, at 9:15 a.m. P.S.T. Initial results from the ADOPT-A study were presented at the North American Society of Pacing and Electrophysiology (NASPE) in Boston, Massachusetts in May.

The AF Suppression(TM) algorithm was recently approved by the FDA for St. Jude Medical's premier pacemaker products, the Integrity AFx(TM) pacemaker and the Integrity(R) Micro DR device. The FDA has also approved a new version of the Company's 3500/3510 programmer software that allows previously implanted Integrity(R) pacemakers to "turn on" the AF Suppression(TM) feature. In addition, St. Jude Medical has announced the first implant of its Identity(TM) pacemaker family, including the AFx(TM) feature set, a suite of diagnostic and therapeutic features designed to better manage pacemaker patients suffering from atrial fibrillation.

St. Jude Medical's AF Suppression(TM) technology, designed for patients with standard bradycardia pacing indications, continuously monitors heart rates and electrically stimulates the atrium slightly above the patient's own rhythm in an attempt to "control" the atrium, thereby suppressing the onset of paroxysmal (brief episodes) and persistent (longer episodes) AF and their associated symptoms.

AF is the world's most common cardiac arrhythmia, affecting over 5 million people worldwide. It is characterized by rapid, uncoordinated and uncontrolled contractions of the atria, the upper chambers of the heart, and keeps the heart from pumping blood efficiently. In the United States, AF represents an immense health care and financial burden, affecting over 2 million people, with annual medical expenditures in the billions of dollars. The prevalence of AF increases strikingly with age - 4 percent of men and women in the U.S. older than 60 and 10 percent of those older than 80 have AF. AF is a common risk factor for - and cause of - stroke. AF also markedly diminishes quality of life and exacerbates heart failure. An estimated 25 percent of heart failure patients also have AF.

Commenting on the presentation of additional results from the ADOPT-A study, Michael J. Coyle, President of the St. Jude Medical Cardiac Rhythm Management Division, said, "Since the initial results of the ADOPT-A study were presented in May, followed shortly thereafter by FDA approval of our AF Suppression algorithm, clinician interest in this technology to better manage the widespread incidence of AF in their pacemaker patients has been very positive. Dr. Carlson's presentation at the upcoming AHA meeting will focus on the effectiveness of the algorithm in suppressing symptomatic organized atrial tachycardias, which are sometimes also present in patients suffering from paroxysmal or persistent AF."

Any statements made regarding the Company's anticipated 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, 2000 (see pages 4-6). Actual results may differ materially from anticipated results. The Company does not undertake any objective to update any statements in this release.

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 unmatched clinical performance and demonstrated economic value.