Bloomberg News

Medtronic Heart Device Didn’t Meet Safety Goals, FDA Says

October 25, 2011

(Adds close of trading in third paragraph.)

Oct. 25 (Bloomberg) -- A catheter-based system made by Medtronic Inc. to treat irregular heartbeat by blocking abnormal electrical impulses failed to meet safety goals in a study, according to a staff report by U.S. regulators.

The Food and Drug Administration will ask an advisory panel to weigh the risks and benefits of using Medtronic’s system to treat a form of the disorder known as atrial fibrillation, the agency said in a report released today. An FDA advisory panel is set to meet Oct. 27 on the Minneapolis-based company’s device.

Medtronic shares fell 2.8 percent to $33.73 at 4 p.m. New York time.

The device works by destroying small amounts of heart tissue to block improper impulses. Study results released by Medtronic on Oct. 10 showed that while the device was effective it fell short of the trial’s safety goals.

“Of particular concern is the high peri-procedural stroke rate observed in the trial,” the FDA staff wrote.

Atrial fibrillation is the most-common type of heart rhythm ailment. It affects 2.2 million people in the U.S., according to the American Heart Association.

During the 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 who underwent traditional medical management.

Patients in the study had a higher risk for adverse events than healthier patients because of the advanced state of the disease Medtronic aims to treat, said John Hummel, director of clinical electrophysiology research at Ohio State Medical Center, in the company’s statement.

Effective for 56%

The trial also showed that the device was effective for 56 percent of patients compared with 26 percent treated with traditional medical management.

Ablation devices that destroy heart tissue to block abnormal electrical impulses 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, according to Medtronic. The device maker is seeking approval to treat patients who experience the heart ailment for long periods of time that require intervention.

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.

St. Jude’s revenue from atrial fibrillation products was $707 million, or about 14 percent of revenue, in fiscal 2010, according to data compiled by Bloomberg.

Market Share

Medtronic’s atrial fibrillation market share is about 8 percent, Matson said. The device maker generated revenue of $147 million from atrial fibrillation revenue treatments in fiscal 2011, less than 1 percent of the company’s total sales, according to Bloomberg data.

The company received approval in December for its Arctic Front Cardiac CryoAblation Catheter, the first cryoballon in the U.S. to treat paroxysmal atrial fibrillation. Medtronic’s atrial fibrillation business grew by more than 40 percent in the most quarter and management expects growth to remain in the 30 percent to 40 percent range, Matson said.

--Editors: Adriel Bettelheim, Reg Gale

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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