Kestra Medical’s ASSURE Wearable Defibrillator Proves Highly Effective and Safe in Largest Real-World Study
Reuters
Nov 10, 2025
Kestra Medical's ASSURE Wearable Defibrillator Proves Highly Effective and Safe in Largest Real-World Study
Kestra Medical Technologies Ltd. has announced primary results from the ASSURE® WCD Clinical Evaluation Post-Approval Study (ACE-PAS), the largest prospective real-world study of wearable defibrillators to date. The results were presented as a late-breaking science session at the American Heart Association (AHA) Scientific Sessions 2025 in New Orleans. The study enrolled 21,612 patients across the United States and demonstrated that the ASSURE wearable cardioverter defibrillator (WCD) achieved 100% successful conversion for ventricular tachycardia and fibrillation events, meeting its effectiveness endpoint. The device also met its safety endpoint, with an inappropriate-shock rate of 0.0065 per patient-month. Additionally, 94% of patients experienced no false positive shock alarms during wear. Further analyses from the study are expected to be shared at upcoming scientific forums.
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