Medtronic Announces FDA Approval of Jewel AF: World's First ICD with New Treatment for Atrial Arrhythmias

New single solution for treatment of irregular heartbeats in both atria and ventricles

MINNEAPOLIS, June 15, 2000 - Medtronic, Inc. (NYSE: MDT), today announced approval by the U.S. Food and Drug Administration (FDA) to market its new JewelŽAF implantable cardioverter defibrillator (ICD). The Jewel AF is the world's first and only ICD to offer new therapeutic capabilities for detecting and treating arrhythmias of the atria (upper chambers), in addition to the ventricles (lower chambers). Once thought relatively benign, fast atrial arrhythmias such as atrial fibrillation (AF), have now been linked to a fivefold increase in the risk of stroke for the five million persons worldwide who have them.

The Jewel AF ICD offers new atrial pacing algorithms and a broad selection of both painless atrial pacing and cardioversion therapies. Its new technological platform employs capabilities of Medtronic's most advanced implantable defibrillators, including the company's proprietary PR Logic™ dual chamber detection algorithm. In addition to standard ventricular diagnostics, the Jewel AF ICD's advanced atrial diagnostics provide physicians with frequency, duration and termination data for atrial arrhythmias. This data, previously only available empirically, enables physicians to better manage their patients' antiarrhythmic drug therapy. The new product is about the size of a small pager, and can be surgically implanted through a small incision in the pectoral area in less than an hour.

"The Jewel AF ICD's ability to treat arrhythmias of the whole heart achieves a new milestone in providing a unique solution for an unmet medical need. For the first time, a single device enables physicians to effectively detect and treat patients with ventricular arrhythmias and who have or may be at significant risk of developing atrial arrhythmias that were often left untreated," said Steve Mahle, president of Medtronic Cardiac Rhythm Management.

Multiple heart rhythm problems have long challenged physicians and severely restricted the lifestyles of patients. Each year in the U.S. alone, more than 550,000 patients experience life-threatening ventricular arrhythmias. Only about 16 percent of them receive ICDs to treat the problem, and until the Medtronic Jewel AF product was available, those patients had little protection from fast atrial arrhythmias.

Atrial arrhythmias are felt as "palpitations" by some, and other patients are almost symptom-free. Yet the debilitating disease weakens and worries most patients and has been shown to be difficult to treat with antiarrhythmic drugs. AF is responsible for more total hospital days than any other cardiac arrhythmia. About 720,000 new patients worldwide are diagnosed each year.

"Many of my patients have commented that the Jewel AF ICD's rapid treatment of their atrial arrhythmia has helped them feel better sooner rather than waiting days or weeks for traditional treatment," said Dr. Charles Haffajee of St. Elizabeth's Medical Center in Boston and Professor of Medicine at Tufts University School of Medicine. "Furthermore, the Jewel AF product now gives me the most comprehensive combination of tools to treat a patient's multiple, complex and changing cardiac arrhythmia problems. It is the first time that a single ICD provides a range of therapies to protect the patient against sudden death and atrial arrhythmias," added Dr. Haffajee.

Clinical data on the Jewel AF was presented at the 72nd Annual Scientific Sessions of the American Heart Association in Atlanta. The data demonstrated that the product's atrial pacing intervention and termination therapies led to a 77 percent reduction in the time study patients spent in their atrial tachyarrhythmias.

Jewel AF devices with commercial labeling will be available in late July.

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