News | October 15, 1998

Medtronic Cleared to Market New Defibrillator

Medical device maker Medtronic Inc. announced this week that it has received premarket approval from FDA to market its GEM DR defibrillator, an implantable device to regulate heart beats.

FDA approved the device in 151 days. While the agency has tried to streamline its evaluation process, the approval of the Gem DR had been expected later in the year, and took several in the industry by surprise.

The Medtronic device performs dual-chamber pacing, a feature that had previously been available in the U.S. only in Guidant's Ventak III device. That feature, giving electronic impulses to both the ventricle and the left atrium of the heart, is crucial to success in the $1 billion-a-year defibrillator industry. That business is growing at a rate of about 30% worldwide.

"We believe that more than 50% of the market will be dual-chamber," said Medtronic's chairman and chief executive, William W. George. "This will give us the chance to take the lead back in the cardiac defibrillator market."