Bloomberg News

Medtronic Defibrillators Win FDA Panel Backing for Wider Use

December 12, 2011

Dec. 7 (Bloomberg) -- Medtronic Inc., the world’s biggest maker of heart-rhythm devices, won the backing of an advisory panel to expand the use of defibrillators that synchronize the right and left chambers of the heart.

The Food and Drug Administration advisory panel voted 3-2 that the benefits of the device outweigh the risks for certain heart patients during a meeting in Gaithersburg, Maryland, Medtronic said today in a statement. The FDA is not required to follow its panels’ recommendations.

The defibrillators from Minneapolis-based Medtronic are approved for patients with moderate and severe heart failure who are fatigued or experience palpitations from below-normal amounts of activity or who can’t carry out tasks without discomfort. The company is seeking to expand the use to people with mild heart failure.

The FDA is concerned that Medtronic is relying on results from a subset of patients chosen after the original study failed to show the devices worked in those with mild heart failure, according to an agency staff report released Dec. 5.

The classifications of heart failure were developed by the New York Heart Association.

The panel also voted 5-0 that the defibrillators are safe and 3-2 they are effective for mild heart failure patients, according to Medtronic’s statement.

Some physicians already use the devices on lower-risk patients, so the market probably won’t grow significantly if expanded use is approved, said Joshua Jennings, a senior research analyst with Cowen & Co. in New York.

“I don’t expect it to be any type of windfall for Medtronic,” Jennings said in a telephone interview.

The FDA approved expanding the use of Boston Scientific Corp.’s cardiac resynchronization therapy defibrillators in September 2010 for patients with mild heart failure, even when they have no outward symptoms.

--Editor: Andrew Pollack, Chris Staiti

To contact the reporter on this story: Anna Edney in Washington at aedney@bloomberg.net.

To contact the editor responsible for this story: Adriel Bettelheim at abettelheim@bloomberg.net.


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