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: LifeVest Wearable Cardioverter Defibrillator, Models 3000, 3100, and 4000
PMA Applicant: Zoll Lifecor Corporation
Address: 121 Gamma Drive, Pittsburgh, PA
Approval Date: December 17, 2015
Approval Letter: Not Yet Available
What is it? The Zoll LifeVest is a wearable cardioverter defibrillator to monitor and treat dangerous, abnormally fast heart rhythms. These abnormal rhythms can lead to a complete absence of heartbeat (sudden cardiac arrest) and death (sudden cardiac death) if they are not treated. This device was first approved for patients 18 years of age and over in 2001, and it is now available for children.
The LifeVest is worn outside the body day and night. It treats abnormal rhythms by applying a high energy shock similar to that of a traditional defibrillator.
How does it work? The LifeVest system consists of two (2) main components:
- an electrode belt that fits within a lightweight garment worn on the patient's chest, and
- a monitor and alarm that the patient wears around the waist.
The LifeVest system continuously monitors a patient's heartbeat. If it detects an abnormally fast heartbeat (ventricular tachycardia), or if the system detects an abnormally irregular heartbeat (ventricular fibrillation), it delivers a high-energy shock.
When the device detects an abnormal heart rhythm, an alarm sequence begins, giving a patient time to stop the treatment if it is not necessary. The patient can prevent a shock by simultaneously pressing two response buttons. If the patient does not respond to the alarm or releases the response buttons, the device continues to alarm and gives a verbal warning that a treatment shock is about to be delivered. Just before a shock is delivered, blue gel within the electrodes is released so the shock will be given efficiently.
When is it used? This device is used to treat life threatening abnormal heartbeats (arrhythmias) in adult and children who are at risk for sudden cardiac arrest and are not candidates for or who refuse an implantable defibrillator. Patients under the age of 18 must have a chest circumference of 26 inches and weigh at least 18.75kg (approximately 43 pounds, the average size of an 8 year old).
What will it accomplish? The LifeVest provides a new treatment option for pediatric patients at risk for sudden cardiac arrest who are not candidates for an implantable defibrillator and for whom additional treatment options may not have been available. The device offers patients the potential for timely defibrillation, the single most important factor in saving a patient with sudden cardiac arrest due to abnormal heartbeats.
When should it not be used? The LifeVest system should not be used in patients who have an active implantable cardioverter defibrillator (ICD).
Additional information (including warnings, precautions and adverse events): Summary of Safety and Effectiveness Data and labeling will be available online.