KIRKLAND, Wash.– Kestra™ Medical Technologies, Inc. announced today that the company has received U.S. Food and Drug Administration (FDA) Premarket Approval for the ASSURE® Wearable Cardioverter Defibrillator (WCD) system.
The ASSURE WCD system represents the next generation of monitoring and therapy to protect patients at risk of Sudden Cardiac Death (SCD). The system includes a modern, comfortable wearable device with integrated sensors, a cardiac rhythm monitor and miniaturized automated external defibrillator. The ASSURE WCD can analyze a patient’s heart rhythm, independently identify a dangerous arrhythmia, make an autonomous treatment decision, and safely deliver defibrillation therapy—a shock to the patient’s heart—to restore a normal heart rhythm. The system is compatible with the company’s cloud based digital health platform that enables communication with both patients and physicians.
“We know WCDs save lives when they are worn, but one of the biggest challenges is getting patients to wear them,” said Brian Webster, CEO. “Kestra designed our first product, the ASSURE system, with the latest available technology, to provide an easier to use and more wearable solution for patients that also delivers high-fidelity data notifications to physicians to improve patient care.”
The company expects the ASSURE system to become available in select markets in the fall of 2021.
