US-based medical device company AtriCure has received expanded CE mark indication approval for its AtriClip devices for the reduction of stroke in patients with atrial fibrillation.
AtriClip is now approved for use in patients at high risk of thromboembolism where exclusion of the left atrial appendage is recommended.
The expanded indication will allow the device to market in CE-marked countries across Europe.
Last month, the medical technology developer received regulatory approval from the National Medical Products Administration (NMPA) of China to market and sell several models of its AtriClip devices.
Ohio-based AtriCure has designed the AtriClip family of devices to offer advanced solutions for excluding, electrically isolating, and eliminating the left atrial appendage during cardiac surgery.
The left atrial appendage (LAA) is a primary source of blood clots in patients with atrial fibrillation (Afib).
This expanded indication is based on clinical evidence and real-world experience, which show that patients who receive an AtriClip device experience a reduction in stroke events.
AtriCure president and CEO Michael Carrel said: “This new indication is tremendous validation of our AtriClip device.
“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.”
The AtriClip device was introduced in 2007 and has been studied in more than 85 peer-reviewed studies that examined both acute and long-term safety and efficacy.
These studies encompass over 11,000 patients from various regions around the world.
AtriCure creates surgical solutions for atrial fibrillation, LAA management, and post-operative pain relief.
Notably, the company’s Isolator Synergy Ablation System is the first US Food and Drug Administration (FDA)-approved device for treating persistent atrial fibrillation.
Other offerings include the AtriClip Left Atrial Appendage Exclusion System, Hybrid AF Therapy, and AtriCure’s cryoICE cryoSPHERE probes.
