The benefits of AtriCure Inc.’s device to treat an irregular heartbeat during open-heart surgery outweigh the risks, advisers to U.S. regulators said.
An advisory panel to the Food and Drug Administration today voted 5-3 with one abstention to recommend the device system for patients with a certain type of the condition known as atrial fibrillation. The agency isn’t required to follow the panel’s advice.
The panel also voted 5-4 with one abstention that the so-called ablation device from West Chester, Ohio-based AtriCure is safe and 9-0 that it is effective to treat persistent irregular heartbeat. The instrument system didn’t appear to meet safety and effectiveness goals when considering the least healthy patients, FDA staff said in a report Oct. 24.
“If this device gets out of the back alleys and into the light in terms of education, then my feeling is we’ll see a better safety profile,” said Robert Jaquiss, a panel member and chief of pediatric cardiothoracic surgery at Duke University Medical Center in Durham, North Carolina.
Atrial fibrillation is the most common type of problem with heart rhythm and affects 2.2 million people in the U.S., according to the American Heart Association.
AtriCure’s device already is approved to destroy heart tissue during surgery. The company is seeking to expand its use to block electrical signals and restore a regular heartbeat as an alternative to therapies such as pacemakers or electrical cardioversion, an electric shock delivered to the chest wall.
Heart surgeons already use ablation systems to treat irregular heartbeat, though no device makers have achieved FDA approval for the use, Matt Dolan, an analyst at Roth Capital Partners in Newport Beach, California, said in an interview.
The company’s shares gained 3 percent to $10.30 in extended trading at 5:29 p.m. New York time after the panel’s decision.
AtriCure studied 55 subjects with atrial fibrillation from nine U.S. sites, according to the FDA’s report on the company’s device. There were five safety failures consisting of two deaths, two cases of excessive bleeding and one stroke, the staff said. Using only the 51 “non-paroxysmal” subjects, the trial “‘just fails to meet the safety performance goal,’’ the agency staff said.
‘‘This supports the contention that the inclusion of ‘healthier paroxysmal AF subjects biases the study toward an overall safety success,’’ the FDA staff wrote.
When viewed with all subjects, ‘‘the trial appears to have succeeded,’’ the agency’s staff said.
Robert Dubbs, the consumer representative on the panel, said today he was reassured by AtriCure’s agreement to do ‘‘extensive training.’’
‘‘I think that can only add to the safety issue,’’ said Dubbs, a member of the survivorship and advocacy committee of the Kimmel Cancer Center in Philadelphia.
AtriCure generated $59 million in revenue last year from cardiac ablation systems, according to data compiled by Bloomberg. Revenue may rise to $74 million in 2012, Vivian Cervantes, an analyst with Kaufman Brothers LP in New York, wrote in a note to clients Oct. 21.
The company expects approval of the new use by the middle of next year, said David Drachman, AtriCure’s president and chief executive officer, in an August earnings call.
The advisory panel tomorrow will weigh a similar catheter-based device from Minneapolis-based Medtronic Inc. The system would treat irregular heartbeat by blocking abnormal electrical impulses, though an FDA staff report yesterday said it failed to meet safety goals in a study.