PANEL CONSIDERATION DOUBTFUL FOR MEDTRONIC PCD DEVICE AT NOVEMBER MEETING
PANEL CONSIDERATION DOUBTFUL FOR MEDTRONIC
PCD DEVICE AT NOVEMBER MEETING
MINNEAPOLIS, Nov. 6 /PRNewswire/ -- In response to an inquiry from the New York Stock Exchange, Medtronic, Inc. (NYSE: MDT), said today that it is doubtful that its Pacer Cardioverter Defibrillator (PCD) device will be reviewed at the U.S. Food and Drug Administration's circulatory systems panel meeting in late November.
FDA panels, comprised of physicians and other specialists knowledgeable about medical or technical issues related to drugs and/or devices under consideration, advise the agency as it processes applications for subsequent commercial approval.
The company expressed concern about the lengthening regulatory process but has continuing confidence in the ultimate approval of its application. Medtronic believes the timing relates to the thorough procedures of the FDA's premarket approval process and not to reservations about the device. FDA approval times have been increasing in the past year and the company believes this situation reflects that change.
Medtronic anticipates continuing progress in the months ahead and expects no significant impact as it continues to work for worldwide market leadership in tachyarrhythmia devices.
The PCD, which has been in clinical trials since 1989, is designed to treat tachyarrhythmia -- an abnormally fast heartbeat. It is receiving excellent acceptance by the medical communities of European countries where it is now on the market. U.S. clinical results also are very positive.
Medtronic, Inc., headquartered in Minneapolis, is a leading developer and manufacturer of biomedical devices for improving cardiovascular and neurological health.
/CONTACT: Dale Beumer, 612-574-3038, or Dick Reid, 612-574-3052, both of Medtronic/
(MDT) CO: Medtronic, Inc. ST: Minnesota IN: MTC SU: AL-JS -- MN014 -- 1892 11/06/91 16:39 EST