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 MINNEAPOLIS, Sept. 13 /PRNewswire/ -- Medtronic, Inc. (NYSE: MDT) announced today that the U.S. Food and Drug Administration (FDA) had approved expansion of clinical evaluation for the Transvene(R) lead system used with its implantable cardioverter-defibrillator, the PCD(R).
 In an announcement coinciding with a meeting of securities analysts, William W. George, president and chief executive officer, said the FDA had authorized the company to increase the number of institutions testing the less-invasive lead system to more than 100. George also said the company had been authorized to add 10 centers each month and expand monthly implants from 200 to 350 while the agency considers commercial release.
 Transvene leads are designed to be maneuvered through the vascular system to deliver therapeutic impulses to the inside of the heart. Medtronic lead systems currently cleared in the United States are attached to the outside of the heart during open-chest surgery.
 In early August, the FDA's circulatory systems advisory panel unanimously recommended the Transvene system for clearance by the agency.
 George also expressed confidence that the company would operate effectively in the changing world health care environments, noting an array of new therapeutic product offerings and the company's long successful experience with the varied medical delivery systems of other major nations.
 Included in other prepared reviews of Medtronic's businesses: Bobby I. Griffin, president of Medtronic's Pacing business, said that Medtronic CardioRhythm, a subsidiary, has submitted a premarketing approval application to the FDA for the Atakr(TM) RF Ablation System. Ablation is a non-surgical technique used to neutralize cells within the heart muscle that have been identified as responsible for starting or maintaining a dangerous heart rhythm. The Atakr is the world's first battery-operated radio frequency ablation system designed to automatically adjust its power output to maintain constant temperature control. More than 300 patients were successfully treated in U.S. clinical evaluations and the system has been commercially released outside the United States.
 Medtronic has entered into a strategic alliance with the Syntex/Synergen joint venture to develop Nerve Growth Factor for delivery into the cerebrospinal fluid by the SynchroMed(R) implantable drug infusion system for potential treatment of Alzheimer's Disease. John Meslow, president of Medtronic's Neurological business, termed the venture "high risk, but potentially a very large opportunity" and added that clinical trials were scheduled to begin in 1994.
 Clinical investigation is under way outside the United States for all five pacemakers of Medtronic's new multi-product Thera(TM) line. Designed to offer the industry's widest range of capabilities and therapies, all employ a common programming interface to make precise adjustment for each patient easier and quicker.
 A long-balloon version of Medtronic's Gold Xchange(TM) rapid- exchange catheter for coronary angioplasty has been released outside the United States while a new long-balloon model of Medtronic's popular 14K(R) over-the-wire catheter has been released worldwide. Jon Tremmel, vice president and general manager of the Medtronic Interventional Vascular business, said the new 30mm. balloons, are designed for safe, effective treatment of long arterial lesions that would require repositioning and repeat inflation of shorter balloons.
 -0- 9/13/93
 /CONTACT: Dale Beumer, investor relations, 612-574-3038; or Dick Reid, public relations, 612-574-3052, both of Medtronic/

CO: Medtronic, Inc. ST: Minnesota IN: MTC SU:

KH-DB -- MN019 -- 1496 09/13/93 17:18 EDT
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Publication:PR Newswire
Date:Sep 13, 1993

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