Medtronic heart devices gets FDA review

Medtronic heart devices gets FDA review

	Published : Wed, 28 Feb 2007 22:09 By : Agencies Print this Story

WASHINGTON (AP) - A panel that advises federal regulators will vote Thursday on whether Medtronic's implantable heart monitoring device, which was not very effective in a company study, should be approved for widespread use.

Minneapolis-based Medtronic seeks Food and Drug Administration approval of its Chronicle device, which would be used by doctors to monitor heart failure patients via computer. Nearly 5 million Americans suffer from heart failure, a chronic condition in which the heart is unable to pump effectively, according to the American Heart Association.

On Thursday, members of the FDA's circulatory system devices panel will decide whether the device appears safe and effective based on company data. The agency is not required to follow the recommendation of the panel, though it often does.

The pacemaker-shaped device is surgically implanted in the upper chest where it records heart pressure, body temperature and other measures. Using an antenna-like device that attaches to a telephone line, the patient transmits information from the device to a Web site where a physician can monitor heart conditions and, ideally, spot problems before they occur.

Medtronic rival St. Jude Medical Inc., which is based in neighboring St. Paul, Minn., is working on a similar device.

In a 274-patient study Medtronic begun in 2003, patients implanted with the Chronicle did not make significantally fewer heart failure-related trips to the hospital, compared with those without the device. While patients in the Chronicle group did have a 21 percent reduction in heart-failure emergencies after six months, that drop is not statistically significant, according to documents posted to FDA's Web site Wednesday.

Additionally, patients with the most severe heart conditions actually showed an increase in heart failure when implanted with the Chronicle. Medtronic notes in its analysis however, that those patients tended to be sicker to begin with than those in other subgroups.

Prudential analyst Larry Biegelsen wrote in a research note last week that Medtronic's device faces are gulatory and commercial challenges.' If approved it could give the company a boost though, since most Wall Street ratings currently do not include potential revenues from the device.

Medtronic and competitors St. Jude and Boston Scientific faced a difficult market last year for their more traditional heart devices, called implantable defibrillators, as year-over-year sales of the devices declined 9 percent, according to Prudential. Defibrillators monitor the heart for deadly irregular heartbeats and use electrical shots to jolt it back to normal.

Medtronic is conducting trials of a new defibrillator that comes equipped with the Chronicle's heart monitoring technology.

In a seperate announcement Wednesday, Medtronic said long-time Chief Executive Arthur Collins will retire in August, though he will remain as chairman until August 2008. He has been with Medtronic since 1992.

Shares of Medtronic Inc. rose 38 cents to $50.32 Wednesday while St. Jude Medical Inc. rose 40 cents to $39.83 on the New York Stock Exchange. Boston Scientific Corp. rose 36 cents to $16.37, also on the NYSE.