Workflow
ASSURE Wearable Cardioverter Defibrillator
icon
Search documents
Largest Real-World Study of Wearable Defibrillators Confirms Strong Effectiveness and Safety Performance of Kestra's ASSURE Device
Globenewswire· 2025-11-10 14:52
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]
Kestra Medical Technologies to Present Late-Breaking ACE-PAS Trial Results at AHA 2025, Showcasing Next-Generation Wearable Defibrillator System
Globenewswire· 2025-11-04 13:00
KIRKLAND, Wash., Nov. 04, 2025 (GLOBE NEWSWIRE) -- Kestra Medical Technologies, Ltd. (Nasdaq: KMTS), a wearable medical device and digital healthcare company, today announced its participation in the American Heart Association (AHA) Scientific Sessions 2025, to be held November 7–10 in New Orleans. Kestra’s participation will include a late-breaking science presentation titled Primary Results from the Post-Approval Study of a Next Generation Wearable Cardioverter Defibrillator System (ACE-PAS Trial), schedu ...
Kestra Showcases Cardiac Recovery System Platform at HFSA 2025, Redefining Sudden Cardiac Arrest Risk Management
Globenewswire· 2025-09-25 12:00
KIRKLAND, Wash., Sept. 25, 2025 (GLOBE NEWSWIRE) -- Kestra Medical Technologies, Ltd. (Nasdaq: KMTS), a wearable medical device and digital healthcare company, today announced its debut at the 2025 Heart Failure Society of America (HFSA) Annual Scientific Meeting, September 26–29 in Minneapolis, Minnesota. At booth #920, Kestra will feature its Cardiac Recovery System® (CRS) platform, anchored by the ASSURE® Wearable Cardioverter Defibrillator. The CRS platform closes the critical gap in sudden cardiac deat ...