Tallahassee, FL 10/27/11 (PennyPayDay) – On Wednesday, U.S. health advisers gave their nod to a label revision for AtriCure Inc's (NASDAQ: ATRC) device for treating a heart rhythm disorder. A panel of outside experts convened by the Food and Drug Administration voted unanimously that the Synergy Ablation System was effective in treating persistent and long-standing persistent atrial fibrillation during open-heart surgery.Votes were divided over safety concerns and, with the panel chairman stepping in, the final vote was 5-4 with one abstention that the device was safe. The panel voted 5-3 with one abstention that benefits outweighed risks.
AtriCure's ablation device is already approved for heart tissue ablation during surgery. It uses radiofrequency energy to remove or destroy problem-causing heart tissue. The company hopes to expand the label to add the use of the device to restore normal heart rhythm in patients with persistent or long-standing persistent atrial fibrillation who require open-heart surgery. If approved for a new label, the AtriCure device would be the first surgical ablation treatment for atrial fibrillation, and third ablation treatment for afib overall.
Atrial fibrillation is the most prevalent heart rhythm disorder. It affects more than 2 million Americans and is a major cause of stroke. In the condition, the heart's upper two chambers contract rapidly and irregularly and don't properly pump blood into the lower chambers. Persistent afib is one that does not go away after seven days or requires intervention to stop; the long-standing persistent kind continues longer than a year.
"The AtriCure team has been working on this project for almost ten years ... We're very proud," CEO Drachman said.
The FDA will make a final decision on the label. It usually follows the advice of its advisers but does not have to.
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