• E-mail
• Print
• Comment
• Font Size
• Digg
• del.icio.us
• Discuss article

Boston Scientific Warns of Flaw in Heart AIDS

Posted on: Tuesday, 16 May 2006, 00:07 CDT

By Jeffrey Krasner, The Boston Globe

May 16--Boston Scientific Corp. yesterday said a batch of defibrillators from its newly acquired Guidant Corp. unit may stop working prematurely because of an electronic defect that causes the batteries to fail.

The problems, disclosed in a warning letter to doctors, affect 996 defibrillators made by Guidant. No deaths or injuries have been linked to the defect, Boston Scientific said, but the battery failures could prevent the defibrillators from functioning properly and restarting a recipient's heart.

The devices were not recalled.

"We are notifying physicians in a timely, transparent, and responsible manner," James Tobin, chief executive of the Natick medical device maker, said in a statement. "This is part of an ongoing process to evaluate the field performance of our cardiac rhythm management products."

Quality problems with other Guidant products enabled Boston Scientific late last year to jump-start a bidding war for the Indianapolis firm. Johnson & Johnson had planned to buy the maker of cardiac devices for $25 billion. But malfunctions in the defibrillators caused seven deaths. Guidant initiated a series of recalls, prompting Johnson & Johnson to lower its bid to $22 billion. That led to a spirited battle between the two companies for Guidant, with Boston Scientific's $27.5 billion offer prevailing in late January.

In February, Guidant said it had received another warning letter from the FDA, citing problems with its defibrillators that could cause some to malfunction. At the time, a Boston Scientific spokesman downplayed the warning, saying his firm had already identified the problems when it was considering buying Guidant.

Defibrillators are implantable devices that monitor the heartbeat of patients with specific kinds of cardiac problems. If the defibrillator detects an aberrant heartbeat or rhythm, it delivers a powerful shock, jolting the heart back into its normal beating pattern.

About 900 of the potentially faulty devices remain implanted in patients. Boston Scientific urged doctors to talk to their patients about the risks.

Paul Donovan, a Boston Scientific spokesman, said yesterday's disclosure is part of the company's effort to "do a better job of communicating" when it discovers product flaws.

Boston Scientific also issued a separate warning yesterday to physicians about another group of defibrillator models. Some of those devices were implanted underneath the chest muscles, the company said, instead of underneath the skin but over the muscles. That positioning caused the defibrillators' titanium cases to wear, again leading to malfunctions. The company said it didn't know how many patients are affected.

Boston Scientific shares lost 13 cents, or less than 1 percent, to close at $20.57. So far this year, its shares have lost about 15 percent of their value.

Because of the FDA warnings, the company is prohibited from exporting certain defibrillators and pacemakers until the agency's concerns are met.

It completed the Guidant purchase April 27 and is rebranding the division to eliminate the Guidant name.

The latest problem won't boost consumer confidence in the Guidant line, said one analyst. "Any evidence that someone had a surgery to get a product [removed] and it might not be working the way it was expected to is a blow to confidence," said Rob Faulkner, of JMP Securities in New York.

Material from Bloomberg News was used in this report.

-----

To see more of The Boston Globe, or to subscribe to the newspaper, go to http://www.boston.com/globe.

Copyright (c) 2006, The Boston Globe

Distributed by Knight Ridder/Tribune Business News.

For information on republishing this content, contact us at (800) 661-2511 (U.S.), (213) 237-4914 (worldwide), fax (213) 237-6515, or e-mail reprints@krtinfo.com.

BSX,

Source: The Boston Globe

More News in this Category