![]() ![]() A second study assessed how well the system returned a dangerously fast heart rhythm to normal by providing a defibrillation shock. It issued very few false shock alerts and properly sensed dangerously fast heart rhythms. Overall the system was well-tolerated in a broad range of adults. Nearly 130 patients took part in it by wearing the system for an average of 22 hours per day for one month. The first study tested the ability of the ASSURE system to sense heart rhythms. 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. ![]() Typical length of use of the Assure system is two to three months. The ASSURE system is intended to be worn 24 hours a day during normal activities except when bathing or swimming. 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. A patient who is awake (conscious) can divert the shock by pressing an alert button if needed. Before the system delivers a shock, the patient will receive an alert. If the system detects the lower chambers of the heart (ventricles) are beating too quickly (ventricular tachycardia), a shock is delivered within 80 seconds. If the system automatically detects a fast, ineffective heart beat (ventricular fibrillation), the needed defibrillation shock is delivered within 40 seconds. The ASSURE system monitors the patient’s heart rate for dangerous heart rhythms. The ASSURE system is worn outside the body (external) and works without additional action from the patient or from bystanders. If necessary, it may deliver an electric “shock" from the defibrillator to restore the heart’s normal rhythm (defibrillation). The ASSURE Wearable Cardioverter Defibrillator System continuously monitors and automatically detects abnormal heart rhythm caused by the heart’s pumping chambers (ventricular arrythmia). PMA Applicant: Kestra Medical Technologies, IncĪddress: 3933 Lake Washington Blvd., NE, Suite 200, Kirkland, WA 98033Īpproval Letter: Approval Order What is it? Product Name: ASSURE Wearable Cardioverter Defibrillator (WCD) System (ASSURE System) 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. This is a brief overview of information related to FDA’s approval to market this product.
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