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Kestra Medical Technologies Receives FDA Premarket Approval for ASSURE Wearable Cardioverter Defibrillator (WCD)

·2-min read

KIRKLAND, Wash., August 03, 2021--(BUSINESS WIRE)--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.

About Kestra Medical Technologies

Kestra Medical Technologies, Inc. is a privately held wearable medical device and digital healthcare company that protects cardiac patients with diagnostic monitoring and therapeutic technologies that are intuitive, intelligent, and mobile. Kestra was founded in 2014 by leaders from the external (AED) and internal (ICD) defibrillation industries. Based in Kirkland, Washington, Kestra’s financial sponsor is Bain Capital.

Forward-Looking Statements

Statements Kestra makes in this press release that relate to future plans, events, prospects or performance are forward-looking statements and as such, are subject to a number of risks, uncertainties, assumptions and other factors that could cause actual results to differ materially from the expectations expressed. While these current forward-looking statements represent the current beliefs of Management as of the date published, Readers are cautioned not to place undue reliance on these forward-looking statements. Except as required by law, Kestra undertakes no obligation to update or revise any forward-looking statements to reflect new information, changed circumstances or unanticipated events.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210803005368/en/

Contacts

Matt Fikse, Kestra Medical Technologies, (425) 708-8445, matt.fikse@kestramedical.com

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