AtriCure Gets CE Mark for EnCompass Clamp

AtriCure has received CE mark approval for its EnCompass clamp, granting the company authorization to sell the device in the EU.
 
The EnCompass clamp, which earned U.S. Food and Drug Administration (FDA) 510(k) clearance in 2022, allows physicians to perform a comprehensive epicardial ablation of the left atrium in a few minutes, according to the company.
 
It includes the features of AtriCure’s existing Synergy clamp family like parallel closure, uniform pressure, and custom power using Synergy radiofrequency (RF). The EnCompass clamp also uses a magnetic guide to help minimize tissue dissection.
 
The clamp was designed to fit cardiac anatomy, supporting surgical ablation in procedures where the atrium wouldn’t normally be opened like CABG and AVR.
 
“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 United States 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.”
 
Last month, the company completed the first surgery using its AtriClip FLEX-Mini device, touted as the smallest profile surgical left atrial appendage (LAA) device on the market.