Cardiology medical device company AtriCure (NASDAQ:ATRC) is aiming to begin in the fourth quarter a clinical trial investigating its AtriClip device in the treatment of stroke patients.
Before that can happen, though, the Cincinnati-area company must complete development of a next-generation version of the AtriClip, a device used to exclude the left atrial appendage during cardiac surgery.
The left atrial appendage is a thumb-sized pouch on the top left side of the heart from which blood clots that cause strokes often originate in patients who suffer from atrial fibrillation, a heart rhythm disorder. Using the clip device to exclude the pouch could reduce the risk of stroke-causing blood clots in patients who can’t tolerate anticoagulation drugs.
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AtriCure is expecting to release a new, next-generation version of the clip device that’s optimized for stand-alone thoracoscopic procedures, which involve inserting a narrow tube with a camera through a small incision in the chest wall.
“What we are waiting for is the next-generation platform, which is specifically designed for the thoracoscopic approach,” CEO David Drachman said in a conference call with analysts.
The new version of the device is expected to be ready for use in humans in July, and Drachman said he expects to obtain U.S. Food and Drug Administration approval to begin testing the device shortly thereafter.
AtriCure would then look to begin enrollment in a 30-patient, six-site safety and feasibility trial in the “early portion of the fourth quarter,” Drachman said.
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The AtriClip currently has U.S. regulatory clearance only for use in conjunction with other open-cardiac surgical procedures in which the physician has direct visualization.
FDA clearance for a stroke label, which isn’t expected to happen for a few years, would widen the potential market for the AtriClip and facilitate long-term commercialization of the device, Drachman has said.
