Cardiology medical device company AtriCure (NASDAQ:ATRC) has received U.S. Food and Drug Administration approval for a stroke safety and feasibility trial of its AtriClip device.
The trial will enroll up to 30 patients at six sites and begin enrollment in the second half of 2012, CEO Dave Drachman said earlier this week in a conference call with analysts.
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The Cincinnati-area company is hoping to obtain a label from the FDA for the AtriClip to be used in standalone procedures that involve exclusion of the left atrial appendage, a thumb-sized pouch on top of the left side of the heart from which blood clots that cause strokes often originate.
The feasibility study is part of the beginning of the process, however. AtriCure doesn’t expect to receive the new label for the AtriClip for several years, chief financial officer Julie Piton said in December.
Here’s how Drachman described the push to obtain the label during the call:
The aim of this project is to start the process of demonstrating that the AtriClip system reduces the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation for whom long-term oral coagulation — anticoagulation therapy — is currently indicated.
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AtriCure is also working on a new version of the AtriClip device that could be used in standalone thoracoscopic procedures, which involve inserting a a narrow tube with a camera through a small incision in the chest wall. The existing version of the device is cleared in the U.S. only for use in conjunction with other open-cardiac surgical procedures in which the physician has direct visualization.
AtriCure plans later this year to submit a 510(k) application for the new AtriClip platform, Drachman said.
