Medical device maker AtriCure (NASDAQ:ATRC) is looking to obtain regulatory clearance to use its AtriClip heart device on stroke patients.
The Cincinnati-area company is planning next year to begin a clinical trial that will investigate the AtriClip for use in stand-alone 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.
Using the clip device to exclude the pouch could reduce the risk of stroke-causing blood clots in patients who can’t tolerate anti-coagulation drugs, said AtriCure CFO Julie Piton.
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But don’t expect the company to obtain clearance for the stroke indication any time soon: Piton said the clinical process to get the label will likely take several years.
Currently, the AtriClip 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. If the company obtains the new clearance it seeks, the device could be marketed for stand-alone thoracoscopic procedures, which involve inserting a a narrow tube with a camera through a small incision in the chest wall.
Obtaining the new clearance would widen the potential market for the AtriClip and facilitate long-term commercialization of the device, CEO David Drachman said during the company’s most recent quarterly earnings conference call with analysts.
Along with the push for a new marketing clearance of the AtriClip, the company is developing a new version of the device’s deployment system, though that doesn’t involve any changes to the clip device itself, Piton said. The changes would make the device easier for surgeons to use in thoracoscopic procedures, she said.
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The AtriClip obtained initial U.S. Food and Drug Administration clearance to begin marketing the AtriClip in June 2010.