Clinical Data On St. Jude Medical Bypass and Valve Devices Presented At Society of Thoracic Surgeons Meeting.

Business Editors & Health/Medical Writers

ST. PAUL, Minn.--(BUSINESS WIRE)--Jan. 30, 2002

Three presentations highlighted clinical data on St. Jude Medical (NYSE:STJ) devices at the Society of Thoracic Surgeons (STS) meeting this week in Fort Lauderdale, Florida. Leading researchers presented their clinical experience with St. Jude Medical's Symmetry(TM) Bypass System Aortic Connector, a sutureless connector device for bypass surgery. In addition, two presentations focused on clinical results of St. Jude Medical(R) mechanical heart valves, including one on the Company's SJM Regent(TM) valve, its next-generation mechanical heart valve.

The Symmetry(TM) Aortic Connector is the first mechanical connector for coronary artery bypass grafting (CABG) surgery. This commercially available device allows cardiac surgeons to attach vein grafts to the aorta without using sutures and eliminates the need to cross-clamp the aorta during bypass procedures.

At the Society of Thoracic Surgeons (STS) meeting yesterday, Michael J. Mack, M.D., with Cardiopulmonary Research Science and Technology Institute in Dallas, Texas, and Robert W. Emery, M.D., with Cardiac Surgical Associates Research Foundation in Minneapolis, Minnesota, presented their initial clinical experience with the Aortic Connector device. The data cover 139 consecutive connector implants in 67 patients during a two-month period following U.S. Food and Drug Administration (FDA) clearance of the Aortic Connector on May 24, 2001.

All the bypass procedures were performed without a heart-lung machine (off-pump). Patient data was analyzed to determine the safety, reliability and ease of use of the Aortic Connector device during CABG surgery.

Initial clinical results showed that the Aortic Connector is safe, reliable and easy to use, according to Dr. Mack and Dr. Emery's presentation. In their experience, 99.3 percent of the bypass anastomoses (connections) were successfully completed. A subgroup of patients were followed with equivalent results to traditional hand sewn anastomoses. Further outcomes will be determined in a randomized study. According to Dr. Mack, "The introduction of this device into clinical use will help usher in a new era of performing bypass surgery."

More than 750,000 bypass procedures are performed annually worldwide, requiring multiple connections between the vein grafts and the aorta (proximal connection) and coronary arteries (distal connection) of the heart. In CABG surgery, the anastomoses are typically the most difficult, time-consuming and critical part of the bypass procedure. The Aortic Connector eliminates the need for sutures, offering a quick, reproducible method to create an anastomosis.

A second study reported on early clinical performance of the SJM Regent(TM) valve, the Company's newest mechanical heart valve. Currently available outside the United States, the SJM Regent(TM) valve is undergoing U.S. clinical trials under an Investigational Device Exemption (IDE).

In the ongoing multicenter trial, data from 361 patients at 17 sites who underwent aortic valve replacement with the SJM Regent(TM) valve were analyzed. Preliminary clinical results demonstrated the excellent hemodynamic performance of the SJM Regent(TM) valve, along with low rates of adverse clinical events. The data showed a significant reduction in LV (left ventricular) mass following valve replacement compared to LV mass measured prior to surgery, as well as single-digit mean pressure gradients (MPG) in 19mm and larger valves.

In another presentation at STS, Dr. Robert Emery reviewed long-term clinical outcomes of younger patients with implanted St. Jude Medical(R) mechanical heart valves in the aortic position. In a study designed to determine the long-term outcome of aortic valve replacement in-patients under the age of 50, 271 patients with St. Jude Medical(R) mechanical heart valve implants were followed over a 20-year period. The data confirmed the excellent clinical performance of the St. Jude Medical(R) mechanical heart valve, reporting a low incidence of complications and valve-related mortality.

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.