Duke University Researchers Present Preliminary Clinical Results For St. Jude Medical's Bypass Connector Device.

Business Editors & Health/Medical Writers

ST. PAUL, Minn.--(BUSINESS WIRE)--Jan. 25, 2002

Data on Symmetry(TM) Bypass System Aortic Connector

Presented at the Cardiothoracic Techniques and

Technologies (CTT) International Symposium

Leading researchers from Duke University Medical Center today presented preliminary clinical data on St. Jude Medical's (NYSE:STJ) sutureless connector device for coronary bypass surgery at the international Cardiothoracic Techniques and Technologies (CTT) symposium in Miami Beach, Florida.

The Symmetry(TM) Bypass System Aortic Connector, the market's first mechanical connector for CABG (coronary artery bypass grafting) surgery, allows cardiac surgeons to attach vein grafts to the aorta without using sutures. The Aortic (or proximal) Connector received U.S. Food and Drug Administration (FDA) clearance in May 2001.

The Duke team, led by Kevin P. Landolfo, M.D., implanted 102 Aortic Connectors in 53 consecutive patients undergoing CABG surgery. Bypass procedures were performed without a heart-lung machine (off-pump) and no clamping of the aorta was required, a benefit of the Aortic Connector device. The study was designed to assess the impact of the Aortic Connector on the incidence of cerebral microemboli, or debris, that can be dislodged during bypass surgery and may cause stroke or other complications.

Two subsets of patients were compared to a matched patient database from previous studies. In the first group, the Aortic Connector patients were compared to patients who had bypass surgery performed on-pump, with clamping of the aorta and traditional suturing techniques. The Duke study's preliminary results showed a significant reduction - an approximate sixfold decrease - in the incidence of cerebral microemboli in this group.

In the second group, Aortic Connector patients were compared to patients who had bypass surgery performed off-pump, with clamping of the aorta and hand-sewn suturing techniques. Although the size of this patient group was not large enough to demonstrate statistical significance, these preliminary results showed a twofold decrease in the incidence of cerebral microemboli.

"Therapeutic strategies that eliminate both cardiopulmonary bypass and aortic manipulation may result in improved neurologic outcomes following coronary bypass surgery," said Dr. Landolfo.

The Duke study also plans to examine patients' postoperative neurological outcomes following use of the Aortic Connector device. The Aortic Connector allows cardiac surgeons to perform quick, reproducible aortic anastomoses (connections) with no cross clamping or side biting of the aorta.

Also at CTT, Dr. Friedrich Eckstein, Assistant Medical Director, Department of Cardiac & Vascular Surgery, at University Hospital, Berne, Switzerland, will present initial clinical results of St. Jude Medical's small vessel connector. The data - first presented at the American Heart Association (AHA) Scientific Sessions in November 2001 - shows that the small vessel connector provides consistently uniform anastomoses with instantaneous hemostasis in significantly less time than hand-sewn techniques.

"These clinical studies underscore the benefits and tremendous potential of our new anastomotic technologies," said Steven J. Healy, President of St. Jude Medical's Cardiac Surgery Division. "The evolution of this technology may ultimately lead to more off-pump CABG procedures, potentially reducing side effects and serious complications for the more than 750,000 patients who undergo this procedure annually."

An estimated 12,000 of the Company's Aortic Connector devices have been implanted worldwide, with approximately 550 cardiac surgeons trained in the U.S. since FDA clearance in May. St. Jude Medical is committed to developing an entire line of aortic and small vessel anastomotic devices to facilitate sutureless CABG and other bypass surgery.

The 8th annual Cardiothoracic Techniques and Technologies (CTT) international symposium exhibits new techniques and technologies in the rapidly evolving field of cardiothoracic and vascular surgery.

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