U.S. regulators said AtriCure Inc. (ATRC)’s alternative during open-heart surgery to treat an irregular heartbeat didn’t appear to meet safety and effectiveness goals when considering the least healthy patients.
The Food and Drug Administration is seeking advice from an advisory panel on whether AtriCure studied its device system in an appropriate variety of patients as it seeks U.S. approval for use against irregular heartbeat, the agency said in a staff report released today. An FDA advisory panel is set to meet Oct. 26 on the West Chester, Ohio-based company’s product.
AtriCure studied 55 subjects with atrial fibrillation, or irregular heartbeat, from nine U.S. sites, according to the report. There were five safety failures consisting of two deaths, two cases of excessive bleeding and one stroke, according to the staff report. 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.
AtriCure fell 13 percent to $10.16 at 4 p.m. New York time, its biggest drop since February 2010.
Irregular heartbeat is the most common type of problem with heart rhythm and can increase the risk of stroke, according to the National Institutes of Health in Bethesda, Maryland. The condition affects more than 5.5 million people worldwide, AtriCure said.
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 so-called 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. Gaining the first regulatory clearance to market their product as an irregular heartbeat treatment may make AtriCure an attractive acquisition target.
“Overcoming that off-label regulatory hurdle would be a positive variable for a potential suitor,” Dolan said.
AtriCure made $59 million in revenue last year from cardiac ablation systems, according to data compiled by Bloomberg. Revenue will reach $79 million for 2012, J.T. Haresco, an analyst with JPMorgan Chase & Co., said in a note to clients Sept. 29.
In its report today, FDA staff said there were two post- operative deaths, two deaths beyond three months but less than six months after surgery and one subject who withdrew from the company’s study in patients with irregular heartbeat.
AtriCure has proposed a post-approval study to evaluate the safety and effectiveness of the device in a real-world setting over the long term, the report said.
AtriCure expects approval of the new use by the middle of next year, said David Drachman, president and chief executive officer, in an August earnings call.
The company applied for approval in February and received a letter from the FDA in March questioning the criteria AtriCure used to define atrial fibrillation patients, said Drachman in a May earnings call. AtriCure worked with the agency during the second quarter to address the questions. They also enrolled 28 of 50 patients in an atrial fibrillation registry, he said in the August call.
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