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MEDTRONIC INFORMS PCD CLINICAL INVESTIGATORS OF ANIMAL STUDY OBSERVATIONS

 MEDTRONIC INFORMS PCD CLINICAL INVESTIGATORS
 OF ANIMAL STUDY OBSERVATIONS
 MINNEAPOLIS, July 20 /PRNewswire/ -- Medtronic, Inc. (NYSE: MDT) said today that it had informed clinical investigators of its PCD system about new observations from animal studies.
 While noting that the animal data included no evidence of a clinical risk to human patients, the company said two animals implanted with the device for more than two years had presented with sarcomas. Medtronic told physicians that the cause of the intrathoracic tumors in the two animals was most probably a phenomenon called "solid-state tumorigenesis" occasionally seen in animals with implants of large surface area materials. The condition is very rare in humans. A third animal suffered a common benign skin tumor not contiguous to the implanted device.
 The company's clinical evaluations and post-market release studies, which are continuing, show no evidence of these tumors in patients with the PCD system. Similarly, the scientific literature shows no indication of tumorigenisis related to implantable cardioverter defibrillators in humans. Implants of the PCD began in 1989. Medtronic told physicians that testing has ruled out any material- or manufacturing-related factors.
 The company has notified the U.S. Food and Drug Administration which is considering the device for commercial release.
 Medtronic, Inc., headquartered in Minneapolis, is a leading developer and manufacturer of biomedical devices for improving cardiovascular and neurological health.
 -0- 7/20/92 R
 /CONTACT: Dale Beumer (Investor), 612-574-3038, or Dick Reid (Media), 612-574-3052, both of Medtronic/
 (MDT) CO: Medtronic, Inc. ST: Minnesota IN: MTC SU:


AL -- MN010 -- 0818 07/20/92 14:27 EDT
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Publication:PR Newswire
Date:Jul 20, 1992
Words:258
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