AtriCure
(Nasdaq: ATRC)
announced today that it received an expanded indication for its AtriClip devices in Europe.
The expanded indication covers patients at high risk of thromboembolism for whom left atrial appendage exclusion is warranted.
Mason, Ohio-based AtriCure designed its AtriClip device to exclude and electrically isolate the LAA during cardiac surgery. LAA can cause blood clots in patients with AFib. The expanded indication came off a body of evidence demonstrating a reduction in stroke events for patients who receive an AtriClip device.
This latest regulatory nod adds to an approval granted by Chinese authorities last month.
“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.”
The left atrial appendage, or LAA space, remains a competitive one that continues to heat up. Investors questioned AtriCure’s position in the space late last year, although analysts labeled it an overreaction. However, that reaction came as significant medtech players joined the fray.
Medtronic, in November 2023, launched the Penditure left atrial appendage (LAA) exclusion device, adding another system to a competitive space. Abbott and Boston Scientific also offer LAA devices, while Johnson & Johnson MedTech made its own play in the market last year, too. AtriCure’s management team said at the time that it welcomes the competition.
