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.
July 23, 2005 |
A recall by Guidant Corp. of certain heart pacemakers has been classified as the most serious type of recall, the Food and Drug Administration said. Guidant's action, announced July 18, was deemed a Class 1 recall, reserved for when there is "a reasonable probability that the malfunctioning device will cause serious adverse health consequences or death."
July 21, 2005 |
Guidant Corp. won a ruling that upholds a patent related to implantable pacemakers and defibrillators, a victory in its bid for royalties from Medtronic Inc., a rival medical device maker. U.S. District Judge Sue Robinson in Wilmington, Del., upheld the validity of the patent. Medtronic filed suit in August 2003 to have the patent invalidated.
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."
January 20, 2005 |
Johnson & Johnson said it would return about $11 billion in foreign profit to the U.S., the first company to declare it will take advantage of a one-year tax holiday. The New Brunswick, N.J.-based maker of a variety of products including Band-Aids and heart stents would record a fourth-quarter cost of $800 million in federal and state taxes to bring home the money, it said in a filing with the Securities and Exchange Commission on Wednesday.
December 21, 2004 |
Guidant Corp. Chief Executive Ron Dollens said Monday that he didn't expect a proposed acquisition by Johnson & Johnson to hamper his company's plans to expand its operations in Temecula. Guidant employs about 2,700 people in Temecula where it manufactures bare-metal stents, devices used to prop open newly unclogged arteries. The fate of the southwestern Riverside County campus was called into question last week after J&J said it was buying Guidant for $25.4 billion.
December 16, 2004 |
Johnson & Johnson, the world's biggest maker of medical devices, said late Wednesday that it agreed to buy defibrillator maker Guidant Corp. for $25.4 billion to gain electrical devices for treating heart disease. In the deal, which had been rumored since last week, New Brunswick, N.J.-based J&J would pay $76 for each share of Indianapolis-based Guidant, 40% of it in cash and the balance in stock, J&J said in a statement. The price for Guidant shares is 10.5% more than on Dec.