Business
AtriCure Announces the First Patient Treated in the LeAAPS™ Clinical Trial
Trial will evaluate the safety and effectiveness of the AtriCure AtriClip® Left Atrial Appendage Exclusion System for stroke prevention in cardiac surgery
About this update from Atricure, Inc.
[{"type":"text","content":"\nTrial will evaluate the safety and effectiveness of the AtriCure AtriClip® Left Atrial Appendage Exclusion System for stroke prevention in cardiac surgery patients\n\n MASON, Ohio--(BUSINESS WIRE)--\nAtriCure, Inc. (Nasdaq: ATRC), a leading innovator in surgical treatments and therapies for atrial fibrillation (Afib), left atrial appendage (LAA) management and post-operative pain management, today announced that the first patient was treated in the Left Atrial Appendage Exclusion for Stroke Prevention (LeAAPS™) clinical trial (NCT 05478304). The patient was treated by U.S. co-principal investigator Dr. Marc Gerdisch at Franciscan St. Francis Heart Center in Indianapolis, Indiana.\n\nLeAAPS is a prospective, randomized, blinded, superiority, investigational device exemption (IDE) clinical trial to evaluate the safety and effectiveness of the AtriClip® LAA Exclusion System for the prevention of ischemic stroke or systemic arterial embolism in cardiac surgery patients at elevated risk for these events and with no history of Afib, which represents a significant proportion of the market. The trial will enroll up to 6,500 patients at up to 250 centers worldwide, making it the largest randomized clinical trial for surgical LAA exclusion. LeAAPS is intended to inform and better define clinical practice and treatment guidelines for stroke prevention in patients undergoing planned cardiac surgery with an elevated risk of ischemic stroke and systemic embolism.\n\n“The LeAAPS trial is a landmark study to evaluate the prophylactic use of AtriClip devices for stroke reduction in cardiac surgery patients without a preoperative Afib diagnosis, laying the groundwork for a new frontier in stroke prevention,” said Michael Carrel, President and CEO of AtriCure. “We have an impressive roster of world-class physicians and hospitals that will be enrolling patients, and we see a substantial opportunity to leverage the AtriClip platform for better long-term outcomes in this patient population while expanding our markets.”\n\nAtriCure first entered the LAA market upon FDA 510(k) clearance of the AtriClip System in 2010. Today, AtriClip System products are the most widely used LAA management devices worldwide. AtriCure plans to use LeAAPS trial results to expand the labeled indications for use of the AtriClip System to include stroke prevention in patie...