Cardiology FDA Cleared

AtriCure wins expanded indications for AtriClip LAA

AtriCure (NSDQ:ATRC) said today that it won expanded 510(k) clearances from the FDA for its AtriClip left atrial appendage device.

The new indications cover a change from occlusion of the LAA to exclusion and adding electrical isolation as a claim, Mason, Ohio-based AtriCure said. AtriClip excludes the LAA and causes its tissue to die from loss of blood supply, eliminating it as an electrical activity source via ischemic necrosis, the company said.

“We continue to demonstrate our leadership in the LAA management space by expanding our labeling claims for AtriClip devices,” president & CEO Michael Carrel said in prepared remarks. “The ability to simultaneously exclude and electrically isolate the LAA using an AtriClip device builds on our growing portfolio of devices. Over the past several years, we have incrementally expanded our labeling to reflect the growing clinical use for AtriClip devices. We anticipate additional labeling expansion in the future as the number of users of AtriClip devices grow.”

“Historically, the surgical amputation of the left atrial appendage in a cut-and-sew fashion was considered to be the gold standard for LAA management,” added Dr. Patrick Whalen of Wake Forest Baptist Health. “The AtriClip device mimics the gold standard by eliminating the LAA by epicardial, mechanical closure. The subsequent ischemic necrosis process ceases all electrical activity in the LAA perioperatively and the appendage is ultimately resorbed.”

“Our research has defined a clear benefit of the electrical isolation of the LAA,” Dr. Dhanunjaya Lakkireddy, of the Kansas City Heart Rhythm Institute, said in a press release. “The AtriClip device excludes the left atrial appendage in a manner that could result in its electrical isolation.”

Earlier this month AtriCure closed the $300 million buyout of SentreHeart and its Lariat left atrial appendage closure device.

ATRC shares were up 0.9% to $27.00 apiece today in late-morning trading.

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