Expanded CE Mark Granted to AtriCure’s AtriClip Devices

AtriCure Inc. has secured an expanded indication for the AtriClip in CE-marked European countries. The product can now be used to treat patients at high risk of thromboembolism for whom left atrial appendage exclusion is warranted.
 
The company’s AtriClip devices are 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 resulted from a significant body of clinical evidence and real-world experience that demonstrates a reduction in stroke events for patients who receive an AtriClip device.
 
“This new indication is tremendous validation of our AtriClip device,” AtriCure President/CEO Michael Carrel stated. “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.”
 
Since the first AtriClip device was used in 2007, there have been more than 85 peer-reviewed studies published on both acute and long-term safety and efficacy. This represents more than 11,000 patients studied across multiple geographies.
 
“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.”
 
AtriCure Inc. provides technologies for treating Afib and related conditi0ons. Afib affects more than 37 million people worldwide. Electrophysiologists, cardiothoracic and thoracic surgeons globally use AtriCure technologies for treating  Afib, reduction of Afib-related complications, and post-operative pain management. AtriCure’s Isolator Synergy Ablation System is the first medical device to receive FDA approval for treaing persistent Afib. AtriCure’s AtriClip Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide, according to the company. AtriCure’s Hybrid AF Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients. AtriCure’s cryoICE cryoSPHERE probes are cleared for temporary ablation of peripheral nerves to block pain, providing pain relief in cardiac and thoracic procedures.