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| |  Clinical Trials Begin for TMR Heart Surgery NORWALK, Conn., Sept. 9, 1996 -- United States Surgical Corporation (NYSE: USS) announced that it has begun phase I clinical trials for transmyocardial revascularization (TMR) -- a surgical procedure that creates pathways for blood to reach oxygen-starved heart tissue in patients with coronary artery problems. The USS TMR system includes a "cold beam" excimer laser and a unique laser delivery system that allows a surgeon to create clean, open channels in the heart. The first case in the trial was performed on Tuesday, September 2, by Dr. Steven R. Gundry, professor and head of Cardiothoracic Surgery at Loma Linda University Medical Center, Loma Linda, Calif. Dr. Gundry stated, "The patient, a 75-year old male, had total blockage of the coronary arteries to the side of his heart, with other vessels to the front and rear of his heart capable of being bypassed in a conventional manner. He received four coronary artery bypass grafts, and 10 laser channels were created on the side of his heart. He was discharged after only three days in the hospital. The area of his heart muscle which received TMR had already improved function." The heart muscle depends entirely on blood supplied by the coronary arteries for nourishment and survival. Although a patient with coronary artery disease has reservoirs of oxygen-rich blood contained in the pumping chamber of the heart, the heart muscle is dying because the blood supply carried by the coronary arteries to the heart wall has been blocked. When a coronary artery becomes partially blocked -- or occluded -- the patient can experience significant chest pain, called angina. Additional occlusion can cause death. TMR is a surgical procedure that uses a laser to "drill" 10 to 30 channels -- each approximately the size of a ballpoint pen tip -- through the damaged heart muscle wall directly into the blood-filled pumping chamber of the heart. These channels allow oxygen-rich blood to flow directly from the chamber to the heart muscle. Researchers believe the benefits of TMR include increased blood flow to obstructed areas of the heart; improved function in the left ventricle; reduction in cardiac pain; reduction in the need for heart medication and improved quality of life. To expedite USS' entry into the TMR market, the company acquired controlling interest in Munich, Germany-based Medolas GmbH in July. Medolas is the leading European developer and manufacturer of TMR products using internally manufactured excimer lasers. Medolas' TMR products have been used on nearly 200 patients, the second largest clinical series in the world. Leon C. Hirsch, chairman of USS, said, "We believe that USS' advanced technology, combined with Medolas' experience, will enable USS to offer a TMR system that will improve care for over 750,000 Americans who require angioplasty and bypass surgery each year." USS' "cold beam" TMR system creates a clean, open channel in a controlled motion, vaporizing the tissue as it advances without causing significant thermal damage. The laser is attached to a state-of-the-art delivery system that synchronizes the laser's penetration rate with its ability to create a channel and employs a unique delivery technology that allows controlled access from any direction. A mechanically-controlled delivery assures consistent, reproducible channeling. Trials will begin shortly at two other sites: The University of Washington, Seattle, Wash., and Allegheny University of the Health Sciences, Philadelphia, Pa. United States Surgical Corporation is a diversified surgical products company specializing in minimally invasive technologies that improve patient care and lower health care costs.
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