Core Insights - Kestra Medical Technologies announced positive primary results from the ASSURE® WCD Clinical Evaluation Post-Approval Study (ACE-PAS), confirming the safety and effectiveness of the ASSURE WCD in clinical practice [1][2][3] Study Overview - ACE-PAS is the largest prospective real-world study of wearable defibrillators, enrolling 21,612 patients across the U.S. from November 2021 to July 2025 [6] - The study provides contemporary data on the risk of life-threatening ventricular tachycardia and fibrillation in patients with reduced cardiac function [2] Effectiveness and Safety - The primary effectiveness endpoint was achieved with a 100% successful conversion rate for ventricular tachycardia and fibrillation events, exceeding the prespecified performance goal [5] - The study met its primary safety endpoint, reporting an inappropriate-shock rate of 0.0065 per patient-month, confirming a strong safety profile [5] - 94% of patients experienced no false positive shock alarms, enhancing user confidence [5] Patient Protection and Compliance - 2.6% of patients experienced at least one life-threatening VT/VF event within a few months, underscoring the importance of the ASSURE WCD for vulnerable populations [5] - The device detected high-rate atrial fibrillation in 4.2% of patients, with 35% previously undiagnosed, and severe bradycardia/asystole in 0.3%, allowing for timely intervention [5] - Patients wore the device for a median of over 23 hours per day, with one-third continuing use beyond 90 days, indicating high compliance in real-world settings [5] Implications for Clinical Practice - The results of ACE-PAS may inform future updates to clinical practice regarding the identification and protection of patients at early risk of sudden cardiac death [3] - The study emphasizes the critical role of wearable device monitoring and therapy in managing sudden cardiac arrest risk [3]
Largest Real-World Study of Wearable Defibrillators Confirms Strong Effectiveness and Safety Performance of Kestra's ASSURE Device