Medtronic likely to win FDA panel nod, analysts say
Tuesday, July 10, 2001
WASHINGTON, D.C. -- A Medtronic Inc. device to treat heart failure is likely to win the backing of an expert U.S. government panel today, analysts said, even as
regulators raise some doubts about the treatment.
The Fridley company's pacemaker-like system is designed to stimulate a weakened heart into beating more effectively. A Food and Drug Administration advisory
panel will consider today whether to recommend that the agency approve the device.
Medtronic's trial failed to show some of the clinical benefits that the company had expected. Still, analysts said the data from the company's research should be enough
to win the panel's support.
The FDA review of Medtronic's InSync device concludes that the system "appears to have met all the statistical safety and effectiveness data set forth in the"
company's application.
The system appears to improve patients' symptoms of severe heart failure -- such as breathlessness and fatigue -- that now must take a cocktail of drugs considered
standard therapy.
FDA officials said another Medtronic device, the AneuRx, should be monitored closely because of its link to 28 deaths. The company's endovascular graft, a
metal-mesh tube that is designed to reinforce weak spots in the aorta, has been linked to 28 cases of ruptured aneurysms, which can lead to fatal hemorrhaging.
Officials at Medtronic said three people have died since the FDA sent out a warning to doctors in April.
The reinforcing stents are considered an alternative to open-heart surgery for patients at high risk for complications. But the problems indicate that the devices should
be monitored closely for five years, FDA regulators said.
-- Bloomberg News
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