Kestra Medical Technologies, founded in 2014 and based in Kirkland, Washington, is a wearable medical device and digital healthcare company focused on protecting cardiac patients at risk of sudden cardiac arrest. The company's flagship product is the ASSURE Wearable Cardioverter Defibrillator (WCD) system, which received FDA premarket approval in July 2021. The ASSURE WCD system is designed to provide autonomous detection and defibrillation for ventricular arrhythmias, as well as detect and record other clinically significant arrhythmias that may require intervention.
The ASSURE system comprises a wearable device, a patient app, and the Kestra CareStation remote patient data platform. It features four channels of ECG, an advanced algorithm, and adaptive patient intelligence to reduce noise and ensure clear data and insights. The system also includes the ASSURE Assist service, which sends an alert to an Emergency Medical Services (EMS) operator after a defibrillation shock. Kestra emphasizes its focus on addressing the needs of underserved female cardiac patients, making the ASSURE WCD the first of its kind designed with specific options for this demographic.
In clinical studies, the ASSURE WCD demonstrated significantly lower false-positive shock alarm rates compared to performance criteria, with no missed true ventricular tachycardia or ventricular fibrillation events. The device also showed low patient-reported discomfort and high wear time compliance. Patients ranging from 21 to 97 years old have been protected by the ASSURE WCD system, with thousands of prescriptions since its introduction.
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