Clinical Trial of Spinal Cord Stimulation for Treatment of Refractory Angina to Start in Fall.

Business Editors & Health/Medical Writers

SAN DIEGO--(BUSINESS WIRE)--Aug. 20, 2002

Therapy has shown potential abroad for relieving unyielding

chest pain in patients who cannot undergo further surgery

A new study sponsored by Medtronic, Inc. (NYSE:MDT), will evaluate the safety and effectiveness of an innovative treatment for the toughest cases of angina, a chronic condition marked by recurrent episodes of suffocating chest pain from lack of oxygen to the heart muscle. The study is slated to start in the fall.

Announced today at the 10th World Congress on Pain, the study will determine whether mild electrical stimulation of the spinal cord -- a therapy already used to treat other types of chronic pain -- can be a safe and effective way to block the pain of severe, chronic, stable angina. Patients with this form of the condition have typically received the full range of possible treatments, including medications and surgical procedures.

Electrophysiologist Dr. Douglas P. Zipes, Distinguished Professor of Medicine and director of the Krannert Institute of Cardiology at Indiana University School of Medicine in Indianapolis, noted that neurostimulation has been used with encouraging results for people with refractory angina in Europe, Canada and Australia. "Carefully controlled studies to evaluate this technique are now needed," Dr. Zipes said. "Success in a clinical trial would solve a frustrating medical problem and enhance the lives of many patients whose quality of life is restricted by almost constant pain."

To treat angina, which affects an estimated 6.4 million Americans and usually results from coronary heart disease, physicians typically prescribe nitroglycerine, angioplasty or bypass surgery. But for about 35,000 patients in the United States alone, the pain persists or increases in frequency and intensity despite receiving all of these treatments. For these cases of intractable angina, the solution might be spinal cord stimulation, which uses an implanted medical device akin to a cardiac pacemaker. Medtronic, the leading maker of the medical technology, is sponsoring this multicenter clinical trial, which has been approved by the FDA. The results could be used to seek FDA approval for this application of spinal cord stimulation.

"The use of spinal cord stimulation to treat the most persistent and difficult cases of stable angina represents an exciting frontier with promising implications for physicians and patients seeking safe and effective alternatives," said Carol Barnett, vice president and general manager of Global Pain Management for Medtronic. "This proven therapy for other pain syndromes, including low back and leg pain, and complex regional pain syndrome, has the potential to improve the lives of people suffering from an intractable form of this painful condition."

Angina patients who have used the therapy outside the United States have experienced pain relief with less medication and fewer visits to the emergency room, according to articles published in the European Heart Journal and the Journal of the American College of Cardiology.

Totally implantable medical technology from Medtronic has been used to treat the chronic pain syndromes of approximately 175,000 people worldwide -- spinal cord stimulation systems since 1981 for about 130,000 patients and infusion systems since 1991 for about 45,000 more.

Organized by the International Society for the Study of Pain (IASP), the 10th World Congress on Pain features numerous research presentations on these therapies for chronic pain of both malignant and nonmalignant origin. Taking place at the San Diego Convention Center, the six-day event began Saturday, Aug. 17 and concludes Thursday, Aug. 22. The official program is available online at www.iasp-pain.org.

Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the world's leading medical technology company, providing lifelong solutions for people with chronic disease. More information about Medtronic Pain Therapies can be found online at www.medtronicpain.com and by calling Medtronic Patient Services at 1-800-510-6735.

Any statements made about the company's anticipated financial results and regulatory approvals are forward-looking statements subject to risks and uncertainties such as those described in Medtronic's Annual Report on Form 10-K for the year ended April 26, 2002. Actual results may differ materially from anticipated results.