(Updates with comment from panelist in fourth paragraph.)
Oct. 27 (Bloomberg) -- Medtronic Inc.’s catheter-based system failed to win a U.S. advisory panel’s backing to treat irregular heartbeat by blocking electrical impulses.
A Food and Drug Administration panel voted 8-2 today that the risks of the Minneapolis-based company’s device outweigh its benefits to treat patients with a form of atrial fibrillation. The agency doesn’t have to follow the advisers’ recommendation.
While the panel meeting today in Gaithersburg, Maryland, voted 10-0 that Medtronic’s so-called ablation system is effective, they decided 9-1 that it isn’t safe for patients who experience the heart ailment for long periods of time and need intervention.
“I recognize these are risky procedures, but the risk seems out of proportion,” said Richard Page, a panel member and a professor at the University of Wisconsin Department of Medicine.
Medtronic’s product works by destroying small amounts of heart tissue to block improper impulses. These ablation devices are approved in the U.S. to treat healthier, or so-called paroxysmal, atrial fibrillation patients whose conditions last at most a few days at a time. Study results released Oct. 10 by Medtronic showed the device was effective for the more severe patients, though it fell short of the trial’s safety goals.
No ‘Material Impact’
A negative panel vote won’t have “a material impact on Medtronic,” the world’s biggest maker of heart-rhythm devices, Kristen Stewart, an analyst with Deutsche Bank AG in New York, said in a note to clients Oct. 25.
Sales of Medtronic’s atrial fibrillation devices are likely to reach $202 million in fiscal 2012 and rise to $394 million in fiscal 2015, driven mainly by marketing of the company’s cryoablation catheter approved in December, Larry Biegelsen, a senior analyst with Wells Fargo & Co. in New York wrote Oct. 25 in a note to clients.
David Steinhaus, medical director in Medtronic’s cardiac rhythm disease management division, said he expects the FDA to make a decision on the device in the “next several months,” giving the company time to decide whether to change course.
“We need to go back and decide how we can best” address safety issues, Steinhaus said in an interview after the vote.
During the clinical trial, 17 patients experienced one or more device-related adverse events, including four who suffered a stroke within seven days of the procedure. The study enrolled 138 patients receiving the Medtronic treatment, and 72 given traditional medical management.
The trial showed the device was effective for 56 percent of patients compared with 26 percent treated with traditional medical management.
“I think that if it gets to the point where quality of life is so low and alternatives have been exhausted, perhaps people should have the right to choose this and I hope that it gets further developed in that sense,” said Scott Evans, a panel member and a senior research scientist at the Harvard School of Public Health in Boston.
Johnson & Johnson, based in New Brunswick, New Jersey, and St. Paul, Minnesota-based St. Jude Medical Inc., lead the ablation market for atrial fibrillation, each with about one- third of the sales, said Michael Matson, an analyst with Mizuho Securities USA Inc. in New York, in a note to clients Oct. 10.
--Editors: Andrew Pollack, Angela Zimm
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