October 14, 2005 |
Guidant Corp. told U.S. regulators that it learned of six additional failures of implantable heart defibrillators since issuing a July notice about the devices used to regulate cardiac rhythms. The failures occurred in the Contak Renewal and Renewal 2 brand of devices, the Food and Drug Administration said. The two devices were among models included in warnings Guidant sent to doctors in June.
June 25, 2005 |
A second safety warning from Guidant Corp., one of the nation's largest medical device manufacturers, urged doctors to stop using five defibrillator models because they could malfunction and may have to be recalled. Indianapolis-based Guidant announced its second worldwide safety advisory in a week Friday, after voluntarily recalling seven defibrillator models last week. The pager-sized, implantable devices sense an irregular heart rhythm and shock the heart back into correct beating.
June 18, 2005 |
Under pressure after malfunctions in at least 45 implanted defibrillators, including two that are suspected in patient deaths, Guidant Corp. on Friday recalled nearly 50,000 of the devices worldwide. For the Indianapolis-based company -- its stock price dropped nearly 2% on the news -- the recall means a financial blow as it prepares to be acquired by health giant Johnson & Johnson. For many patients, it means surgery to replace suspect devices.
June 3, 2005 |
Medical device maker Guidant Corp. on Thursday stood by its decision to continue selling an implantable heart defibrillator for months after a potential flaw prompted a redesign, saying the original device was still reliable. "The reliability data showed that the original Ventak Prizm 2 DR, like the enhanced version, was a highly reliable lifesaving product," said Steve Tragash, Guidant's director of corporate communications. "Current data continues to support the reliability of this product."
May 25, 2005 |
Guidant Corp. said it had notified regulators about problems with its defibrillators and said it was working with the Food and Drug Administration. Guidant, in a letter to doctors dated May 23, said a line of its implantable defibrillators contained a flaw that had caused a small number of them to malfunction, but it did not recommend the products be replaced. Guidant said the clinical performance of its device, the Ventak Prizm 2 DR ICD, "continues to exceed design expectations."
March 2, 2005 |
Will Kimble leaned forward, touching his chest just below his left shoulder. "If you want to feel it, you can," he said. There, implanted beneath his skin but easily felt through his shirt, is a defibrillator, designed to shock his heart back into a normal rhythm if it detects an irregular heartbeat.
December 8, 2004 |
Johnson & Johnson, the world's biggest maker of medical devices, may buy defibrillator maker Guidant Corp. for $24 billion, people familiar with the situation said Tuesday. Shares of Guidant jumped 5.2% and Johnson & Johnson fell 2.3% after the New York Times reported the companies were in talks, citing unnamed company executives. The two haven't agreed whether a purchase of Guidant, the No. 2 maker of implantable defibrillators, would be with cash, stock or a combination, said the people, who declined to be named.
September 17, 2004 |
The Food and Drug Administration decided Thursday that consumers can buy devices to jump-start failing hearts at home without a prescription. About 80% of sudden cardiac arrests occur at home. Before the agency's decision, consumers who wanted a HeartStart home defibrillator to use in those crucial minutes before an ambulance arrived needed a doctor's prescription.
August 2, 2004 |
Some have called it a jump-starter for the human heart. But the maker of a new automatic external defibrillator wants Americans to think of it as just another safety device for the home -- vital and user-friendly, like a fire extinguisher.
February 21, 2004 |
Boston Scientific Corp., the third-biggest maker of stents that prop open arteries, bought a stake in Cameron Health Inc., which is developing a wireless form of implantable defibrillators, devices that regulate heartbeats. Boston Scientific also acquired an option to buy all of San Clemente, Calif.-based Cameron. Terms of the investment weren't disclosed. Cameron has implanted its defibrillators in about 90 patients outside the U.S. and is talking to the Food and Drug Administration about U.S.