Indianapolis, IN - Once again, Guidant Corp has announced problems with thousands of pacemakers and is suggesting that physicians should consider replacing the devices in almost 20 000 patients worldwide [1]. The move, likely to be dubbed an "expanded" recall by the FDA, comes as Guidant had been basking at the center of a bidding war between Boston Scientific and Johnson & Johnson (J&J). Boston Scientific currently has the highest offer on the table and has said the new pacemaker revelations from Guidant will not affect the deal. J&J has until midnight tonight to come up with a new offer; however, it was Guidant's 2005 recall woes that first put a 2004 J&J buyout offer on the rocks and opened the door to the rival bid from Boston Scientific.

In a statement released yesterday, Guidant acknowledged that an additional 54 000 devices not included in a July 2005 pacemaker recall may also be prone to malfunction, a result of faulty hermetic seals. A total of five incidents have occurred, of which two involved hermetic-seal degradation; the company estimates that 19 300 of the faulty devices have been implanted worldwide. The new incidents raise the overall projected rate of events to between 0.31% and 0.88%, up from the July 18, 2005 estimate of 0.17% and 0.51%, for Guidant devices listed in the recalls. The projected rate of adverse events within the newly identified series of devices is lower, however, than this overall rate, ranging from 0.02% to 0.06%, the statement notes. As such, "physicians should consider the much lower projected rate of occurrence and the needs of each individual patient, including pacemaker dependence, when making patient management decisions for patients."

The recall may put an end to the Guidant acquisition battle that began in early December 2005, as reported by heartwire.J&J first offered Guidant $25.4 billion in 2004, later dropping the offer price to reflect Guidant's device recalls. In the past two months, Boston Scientific has twice upped J&J's buyout bid, then at $19 billion, first offering $25 billion, then, on Jan 17, $27 billion, after J&J countered at $24.2 billion. Industry analysts widely quoted in the media this morning are divided as to whether the new recall news will be enough to convince J&J to walk from the proposed deal or whether the bigger company is just waiting until the 11th hour to deliver yet another offer.

In the safety alert, Guidant is offering patients who were implanted with a faulty device a no-cost replacement and up to $2500 in unreimbursed medical expenses until June 30, 2006. The offer applies to devices identified in the first recall, as well as those singled out in this latest alert. These include Guidant's Contak TR, Discovery, Discovery II, Intelis II, Meridian, Pulsar, Pulsar Max, Pulsar Max II, and Virtus Plus II models, manufactured between October 1997 and October 2000.