Oct. 27 (Bloomberg) -- AtriCure Inc., maker of surgical devices, climbed the most in 16 months after a U.S. regulatory panel recommended approval of the company’s product for irregular heartbeats.
AtriCure surged 20 percent to $11.97 at 10:25 a.m. New York time. The West Chester, Ohio-based company earlier reached as high as $12.09 in the largest intraday increase since June 15, 2010.
An advisory panel to the Food and Drug Administration voted yesterday to clear the device system for patients with a certain type of the condition known as atrial fibrillation. The advisers said the benefits of the product outweighed any risks. The agency isn’t required to follow the panel’s advice.
The advisers also said the so-called device is safe and 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.
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.
--Editors: Bruce Rule, Reg Gale
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