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Medtronic Launches New Gem DR Implantable, Dual Chamber Pacing And Defibrillation Device.

MINNEAPOLIS, Oct. 12 /PRNewswire/ -- Medtronic, Inc. (NYSE: MDT), today announced pre-market approval by the Food and Drug Administration (FDA) and commercial release in the United States of the Medtronic Gem(TM) DR, the world's most technologically advanced implantable defibrillator for treating complex heart rhythm problems. The Gem DR device is the first dual chamber defibrillator designed on a new platform that fully integrates microelectronics and software to combine the functions of defibrillators and rate responsive pacemakers.

Offering significant, patient-friendly improvements in supplying therapeutic shocks for fast heartbeats only when needed, the Gem DR defibrillator (Model 7271) also provides full-featured dual chamber, rate responsive pacing and synchronization for rhythms that are too slow in either the upper or lower chambers of the heart. Rate responsive pacing senses bodily movement and adjusts its pacing rate to the patient's activity level.

"We believe the Gem DR sets a new standard in dual chamber defibrillators," said William W. George, chairman and chief executive officer of Medtronic. "The approval of this breakthrough technology by the FDA in just 151 days for thorough review of a full PMA makes it an outstanding example of the agency's new procedures that employ interaction and open communication with industry to speed medical device solutions to U.S. patients."

"The rapid acceptance of the Gem DR by European physicians is indicative of the exceptional qualities of this product. Since release there in late June, European sales have increased at an accelerating rate," George said.

The Gem DR incorporates PR Logic(TM), an innovative dual chamber detection algorithm designed to discriminate between fast ventricular rhythms that are life-threatening and fast atrial arrhythmias that are not. This technology combines atrial and ventricular information to analyze heart rhythm patterns much as a physician does when reviewing rhythm patterns on an electrocardiogram.

"PR Logic provides the physician with a new level of confidence that the Gem DR will deliver prescribed therapy rapidly for life-threatening arrhythmias but withhold it when arrhythmias are not life-threatening," said Charles D. Swerdlow, M.D., of Cedars-Sinai Medical Center, Los Angeles, CA. Dr. Swerdlow was a key contributor to development of the PR Logic algorithm.

Clinical evaluations involving 300 patients have demonstrated the Gem DR device's ability to sharply reduce inappropriate treatment of atrial arrhythmias -- including atrial fibrillation, atrial flutter, sinus tachycardia and other supraventricular tachycardias. In these evaluations, the Gem DR detected and treated successfully more than 99 percent of ventricular arrhythmias while significantly reducing the inappropriate treatment of atrial arrhythmias.

Despite being only about the size of a pager -- 62 cc -- the device is designed to deliver up to 35 joules of therapeutic energy and is expected to offer 7-9 years of service in typical use.

Jon Tremmel, president of Medtronic's tachyarrhythmia product line, noted that, "We believe that the Gem DR device not only matches what customers have requested -- its features herald a new generation of technological sophistication that sets an industry standard in the management of ventricular tachyarrhythmia patients."

The Gem DR device is the first in the industry offering the capability to automatically check the effectiveness of its electrical leads without delivering painful test shocks. It also includes a Patient Alert(TM) feature which enables the device to continuously monitor its performance and alert the patient with an audible tone when it has collected data for which physician attention is required -- for example, if the device has low battery voltage or its lead impedance is not within an acceptable range.

To aid in diagnosis and followup, the Gem DR has two channels for recording or displaying high-fidelity stored electrograms and can store up to 22 minutes of diagnostic information from the atrium or ventricle or 12 minutes of information simultaneously from both chambers. The electrogram is accompanied by Flashback(TM) Memory, a unique diagnostic aid that provides key graphical information about the history and onset of tachyarrhythmia episodes.

A second product in the new Medtronic family of defibrillators, the Medtronic Gem (Model 7227), was approved by the FDA on October 5, 1998. It offers many of the features of the Gem DR in a single chamber version for patients not requiring the dual chamber pacing support.

Another Medtronic dual chamber product, the Jewel(R) AF arrhythmia management device (Model 7250), was commercially released in Europe and other international markets in late June. The Jewel AF device is designed to offer therapy options for atrial arrhythmias. It continues in U.S. evaluation.

Medtronic, Inc., headquartered in Minneapolis, is the world's leading medical technology company specializing in implantable and invasive therapies. Its Internet address is
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Publication:PR Newswire
Geographic Code:1USA
Date:Oct 12, 1998
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