WASHINGTON (AP) A government advisory panel voted to approve a pacemaker for people with congestive heart failure, but rejected a different device that included a defibrillator.
The panel of outside experts voted 7-0 in favor of approving Medtronic Corp.s InSync heart pacing device for people suffering congestive heart failure.
In recommending approval, the committee urged some labeling changes and said approval should be conditional on continued follow-up of participants in the clinical trials.
Earlier in the day the group concluded 6-to-2 that Contak CD, made by Guidant Corp., didnt meet the necessary effectiveness standards.
The FDA is not required to follow the recommendations of its advisory panels, but it most often does so.
The Guidant machine combines a defibrillator with an electrical device that helps regulate the beating of the heart. Its designed to assist people with failing hearts and can detect unusual rhythms and stimulate the heart with electrical pulses to restore proper beating. The company had sought approval for use of Contak CD in patients with congestive heart failure.
Some heart pacers with defibrillators are on the market, such as that recently implanted in Vice President Dick Cheney, but his device does not have the type of heart regulator that the Guidant machine includes.
Earlier this year, Guidant drew criticism from the FDA for claims it made about its device in a press release. Later, however, the FDA said an agency spokeswoman went too far in that criticism.
Copyright © 2001, Associated Press. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.