Kestra announces results from ASSURE WCD clinical evaluation post-approval study

Kestra Medical (KMTS) announced primary results from the ASSURE WCD Clinical Evaluation Post-Approval Study, presented as a late-breaking science session at the American Heart Association Scientific Sessions 2025 in New Orleans. ACE-PAS, the largest prospective real-world study of wearable defibrillators to date, confirmed the strong safety and effectiveness of the ASSURE WCD in clinical practice. The study enrolled 21,612 patients across the United States. Key findings demonstrate consistent safety, effectiveness, and compliance in real-world use The primary effectiveness endpoint was achieved, with 100% successful conversion for ventricular tachycardia and fibrillation events, surpassing the prespecified performance goal. The study met its primary safety endpoint, with an inappropriate-shock rate of 0.0065 per patient-month, below the prespecified performance goal and confirming a strong safety profile.94% of patients experienced no false positive shock alarms, ensuring confidence and comfort during wear. 2.6% of patients experienced at least one life-threatening VT/VF event within only a few months, highlighting the importance of protection in this vulnerable population. The ASSURE system facilitated detection of high-rate atrial fibrillation in 4.2% of patients and severe bradycardia/asystole in 0.3%, enabling the potential of timely intervention.Patients wore the device for a median of more than 23 hours per day, and one-third continued use beyond 90 days-highlighting its practicality in real-world, long-term care.