AtriCure has received regulatory approval to sell the EnCompass clamp in CE-marked countries in the European Union, and European surgeons have recently performed the first series of cases with the device. The EnCompass clamp received US Food and Drug Administration (FDA) 510(K) clearance and was launched in the USA in 2022.
“Launching our EnCompass clamp in Europe represents a significant expansion of our product line internationally,” said Michael Carrel, president and CEO of AtriCure. “We have seen this product have a positive impact in the USA over the last two years by advancing treatment concomitant to cardiac surgery. We are excited to offer this safe, innovative, and effective therapy to patients and our physician partners in Europe.”
The EnCompass clamp provides a simpler and faster approach to ablating the heart in open-chest procedures, allowing physicians to perform a comprehensive epicardial ablation of the left atrium in just a few minutes. The EnCompass Clamp includes the features of AtriCure’s existing Synergy clamp family, such as parallel closure, uniform pressure, and custom power using Synergy radiofrequency (RF).
The EnCompass Clamp also allows for easier placement using a magnetic guide, which enables more efficient procedures by minimising tissue dissection. Further, the EnCompass clamp is designed to fit cardiac anatomy, supporting surgical ablation in procedures where the atrium would normally not be opened such as CABG [coronary artery bypass grafting] and AVR [aortic valve repair]. AtriCure estimates approximately 400,000 cardiac surgeries occur annually in the European Union.
