BY OUR PHARMA CORRESPONDENT
19 July, 2005: The Indianapolis-based Guidant Corporation issued an alert to doctors that some of the patients using its pacemakers might need to have the units replaced as nine of its older pacemaker models were prone to failing.
The alert covers 28,000 pacemakers made from November 1997 to October 2000 and still implanted in patients. Guidant said that a component used to seal the pacemakers could degrade, allowing moisture to build up and causing the devices to fail. Such failure could cause "serious health complications" in some patients, the company said.
The company is already embroiled in controversy over recall tens of thousands of implantable heart defibrillators in recent weeks.
A statement from US FDA said the agency was aware that Guidant had issued the pacemaker alert to doctors and that it was evaluating the matter. Guidant said it expected the FDA to designate the alert as a recall, a formal classification that involves the type of physician notification that Guidant is already making.
A recall does not mean that a device should be removed. Instead, patients are typically advised to discuss with their doctors the risk posed by a device compared with the risk posed by the surgical procedure needed to replace it.
The nine older pacemaker models are involved are the Pulsar Max, the Pulsar, the Discovery, the Meridian, the Pulsar Max II, the Discovery II, the Virtus Plus II, the Intellis II and the Contak TR. The units, which are of an earlier design, have not been implanted for the last four years, the company said.
Guidant said it had identified 69 devices that may have had the seal problem, out of some 78,000 devices in which that component was used. Currently, about 28,000 of those units are still implanted in patients, with 18,000 of them in the United States.
In 20 known cases, the problem caused pacemakers to fail, and in 5 such instances, patients blacked out, apparently because of inadequate blood flow. In two other instances, the flaw may have caused a pacemaker to keep pacing at a high rate.
In one such case, that flaw may have contributed to a patient's death. However, because the unit was not returned to Guidant for inspection, the company said it was not clear if the death was related to the device or to the patient's health problems.
Guidant Corporation develops, manufactures and markets products including coronary stent systems, dilatation catheters, intravascular radiotherapy systems and related accessories, implantable defibrillator systems, implantable pacemaker systems, angioplasty systems, cardiac surgery systems, implantable cardiac resynchronization therapy. The group has principal operations in the United States, Europe, Asia and Japan.
Guidant's recent spate of recalls is likely to play a role in discussions of second-quarter earnings results due this week from both Guidant and Johnson & Johnson, which agreed in December to buy Guidant for $25.4 billion.