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AtriCure Receives Expanded CE-Mark Indication for AtriClip® Devices for the Reduction of Stroke in Patients with Atrial Fibrillation
Expanded indication based on an abundance of clinical evidence for AtriClip Devices MASON, Ohio--(BUSINESS WIRE)-- AtriCure, Inc. (Nasdaq: ATRC), a leading
About this update from Atricure, Inc.
[{"type":"text","content":"\nExpanded indication based on an abundance of clinical evidence for AtriClip Devices\n\n\n MASON, Ohio--(BUSINESS WIRE)--\nAtriCure, Inc. (Nasdaq: ATRC), a leading innovator in surgical treatments and therapies for atrial fibrillation (Afib), left atrial appendage (LAA) management, and post-operative pain management, today announced that it has received an expanded indication for the AtriClip® in CE-marked countries in Europe. The product is now indicated for use in patients at high risk of thromboembolism for whom left atrial appendage exclusion is warranted.\n\n\nThe AtriClip family of devices are innovative solutions designed to exclude, electrically isolate, and eventually eliminate the left atrial appendage during cardiac surgery. The LAA is a major source of blood clots in patients with Afib, and this expanded indication is a result of a significant body of clinical evidence and real-world experience that demonstrates a reduction in stroke events for patients who receive an AtriClip device.\n\n\n“This new indication is tremendous validation of our AtriClip device,” said Michael Carrel, President and CEO of AtriCure. “With over 550,000 patients successfully treated worldwide, we have seen the impact that our devices have on patient care. The expanded indication from the European Commission confirms our own clinical evidence that strokes can be reduced in patients who are at high risk of developing thromboembolism, and we continue to see strong opportunity to grow adoption of mechanical appendage closure.”\n\n\nSince the first AtriClip device was used in 2007, there have been over 85 peer-reviewed studies published on both acute and long-term safety and efficacy. This represents over 11,000 patients who were studied across multiple geographies.\n\n\n“I’ve been using AtriClip devices for over a decade and have seen firsthand the benefits of its safety and efficacy,” said Professor Dr. Med. Nicolas Doll, Chief Physician of Cardiac Surgery, Schuechtermann-Clinic, Bad Rothenfelde, Germany. “The devices are easy to use, and they provide patients with the benefit of long-term prevention of stroke, which makes adoption of the AtriClip an easy decision.”\n\n\nForward-Looking Statements\n\n\nThis press release contains “forward-looking statements”– that is, statements related to future events that by their nature address matters tha...