FDA Clears Medtronic LIFEPAK 12 Biphasic External Defibrillator for Two Additional Uses in Cardiac Care.

Business Editors & Health/Medical Writers

MINNEAPOLIS--(BUSINESS WIRE)--Aug. 27, 2001

Patients Report Less Pain with ADAPTIV(TM)

Waveform Treatment of Atrial Fibrillation

Medtronic Physio-Control today announced that the U.S. Food and Drug Administration has cleared the biphasic LIFEPAK(R) 12 defibrillator for use in cardioversion of atrial fibrillation (AF) and open chest defibrillation. Importantly, a supporting study demonstrated that AF patients treated with the LIFEPAK 12 defibrillator's escalating ADAPTIV(TM) biphasic technology experienced significantly less pain after the procedure than did patients treated with other available technology.

In the randomized clinical trial involving patients with atrial fibrillation, ADAPTIV biphasic shocks achieved significantly higher efficacy, requiring fewer shocks and 65 percent less energy and current than conventional monophasic shocks. Overall, 97 percent of patients treated with escalating ADAPTIV biphasic shocks were converted (restored to a more normal heart rhythm), compared to 86 percent of those treated with monophasic shocks.

The escalating ADAPTIV biphasic technology -- exclusive to Medtronic Physio-Control -- is particularly relevant for the 10 percent to 15 percent of patients whose thoracic impedance may prevent successful conversion to a normal heart rhythm at low energy doses. The LIFEPAK 12 defibrillator offers energy levels up to 360 joules to maximize the procedures' likelihood of success.

Jon Tremmel, President, Medtronic Physio-Control, noted, "We are pleased to now provide two new clinical uses for escalating ADAPTIV biphasic technology, coupled with a significant reduction in pain for the AF patients and more security for the user. This clearance gives the LIFEPAK 12 product the widest range of clinically tested uses of any biphasic defibrillator. Escalating ADAPTIV technology provides patients and healthcare professionals confidence and peace of mind."

Atrial fibrillation, associated with a fivefold increase in the risk of death from stroke and a major cost to healthcare systems, is estimated to affect 5.5 million people worldwide. During its debilitating episodes, the heart rhythm loses its coordination, and the upper chambers race ineffectively at 300-600 beats per minute rather than the normal 60-100. Elective treatment of atrial fibrillation episodes represents the most prevalent use of hospital defibrillators, with more than 89,000 such procedures occurring in U.S. hospitals annually. Patients often experience intermittent episodes, and it is expected that they will undergo repeat cardioversion procedures more willingly as use of the ADAPTIV biphasic technology becomes associated with less post-procedure pain.

Medtronic Physio-Control is the world's leading provider of external defibrillators with proprietary ADAPTIV biphasic escalating technology and a full line of instruments and accessories for use in treating life-threatening heart rhythms. Its innovative ADAPTIV biphasic technology is also offered in the LIFEPAK 500 AED, a lightweight, easy-to-use automated external defibrillator that requires only minimal training to administer its lifesaving therapy.

Medtronic, Inc. (NYSE:MDT), headquartered in Minneapolis, is the world's leading medical technology company, providing lifelong solutions for people with chronic disease. Its Internet address is www.medtronic.com.

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 27, 2001. Actual results may differ materially from anticipated results.