This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: ASSURE Wearable Cardioverter Defibrillator (WCD) System (ASSURE System)
PMA Applicant: Kestra Medical Technologies, Inc
Address: 3933 Lake Washington Blvd., NE, Suite 200, Kirkland, WA 98033
Approval Date: July 27, 2021
Approval Letter: Approval Order
What is it?
The ASSURE Wearable Cardioverter Defibrillator System continuously monitors and automatically detects abnormal heart rhythm caused by the heart’s pumping chambers (ventricular arrythmia). If necessary, it may deliver an electric “shock" from the defibrillator to restore the heart’s normal rhythm (defibrillation). The ASSURE system is worn outside the body (external) and works without additional action from the patient or from bystanders. *Each style has seven sizes available.
How does it work?
The ASSURE system monitors the patient’s heart rate for dangerous heart rhythms. If the system automatically detects a fast, ineffective heart beat (ventricular fibrillation), the needed defibrillation shock is delivered within 40 seconds. If the system detects the lower chambers of the heart (ventricles) are beating too quickly (ventricular tachycardia), a shock is delivered within 80 seconds. Before the system delivers a shock, the patient will receive an alert. A patient who is awake (conscious) can divert the shock by pressing an alert button if needed.
When is it used?
The ASSURE system is available by prescription only and is indicated for use by patients who are at risk for sudden cardiac arrest and who cannot or will not use a defibrillator that is implanted inside the body. The ASSURE system is intended to be worn 24 hours a day during normal activities except when bathing or swimming. Typical length of use of the Assure system is two to three months.
What will it accomplish?
Two clinical studies were conducted to test the ASSURE system’s safety effectiveness at detecting abnormal ventricular heart rhythms and defibrillation with a low rate of false alarms. The first study tested the ability of the ASSURE system to sense heart rhythms. Nearly 130 patients took part in it by wearing the system for an average of 22 hours per day for one month. Overall the system was well-tolerated in a broad range of adults. It issued very few false shock alerts and properly sensed dangerously fast heart rhythms. A second study assessed how well the system returned a dangerously fast heart rhythm to normal by providing a defibrillation shock. This study included 13 patients who all had heart rhythms restored to normal by the system.
When should it not be used?
The ASSURE system should not be used if a patient has an active implantable defibrillator (ICD).
Additional information (including warnings, precautions, and adverse events):
- Summary of Safety and Effectiveness Data (SSED)
- Physician Labeling
- Patient Handbook
- PMA Database Entry