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Largest cardiac surgery device trial ever with 6,500 patients enrolled, this landmark trial evaluates the stroke reduction benefit with AtriClip devices for the over one million cardiac surgery patients globally without a preoperative Afib diagnosis
AtriCure, Inc. (NASDAQ:ATRC), a leading innovator in surgical treatments for atrial fibrillation (Afib), left atrial appendage (LAA) management, and post-operative pain management, today announced the completion of enrollment in the left atrial appendage exclusion for prophylactic stroke reduction (LeAAPS) clinical trial (NCT05478304). Initiated in January 2023, LeAAPS enrolled 6,500 patients across 137 centers globally.
LeAAPS is a prospective, randomized, blinded, superiority, investigational device exemption (IDE) trial evaluating the AtriClip® LAA Exclusion System for the prevention of ischemic stroke and systemic arterial embolism in cardiac surgery patients without a history of Afib—a large and often underserved population at elevated risk for these events. It is estimated that well over one million cardiac surgery procedures occur annually and more than 70% of these patients have no history of Afib before surgery.
AtriCure first entered the LAA management market with FDA 510(k) clearance of the AtriClip System in 2010. Today, AtriClip devices are the most widely used LAA management device worldwide. The company plans to use LeAAPS data to support an expanded indication for stroke prevention in patients at elevated risk of ischemic stroke.
Posted In: ATRC
