FDA Approves Wearable Defibrillator for Children at Risk for Sudden Cardiac Arrest

January 2016 - In the News - FDA Updates

The U.S. Food and Drug Administration today approved a new indication for the LifeVest wearable cardioverter defibrillator. The LifeVest is approved for certain children who are at risk for sudden cardiac arrest, but are not candidates for an implantable defibrillator due to certain medical conditions or lack of parental consent.

While many automated external defibrillators (which require a second person to operate them) have been cleared for use in children, LifeVest is the only one worn by the patient and monitors the heart continuously for abnormal, life-threatening heart rhythms (arrhythmias). LifeVest responds automatically if it senses the need to deliver a shock, restoring a life-sustaining heartbeat.

“The pediatric medical community is often forced to use adult devices off-label without appropriate labeling or instructions for use in pediatric patients,” saidVasum Peiris, M.D., M.P.H., Chief Medical Officer of Pediatrics and Special Populations in the FDA’s Center for Devices and Radiological Health. “Doctors now have important information that may help them safely prescribe this life-saving device to young patients who may benefit from the device.”

A life-threatening abnormal heart rhythm, referred to as ventricular fibrillation (V-fib) or ventricular tachycardia (V-tach), is the most common cause of sudden cardiac arrest, according to the National Heart, Lung and Blood Institute. Certain diseases and conditions that can lead to sudden cardiac arrest include heart disease, certain inherited disorders and structural changes in the heart (such as those due to infection or congenital heart disease). Most people who have sudden cardiac arrest will die from it, often within minutes. Rapid treatment with a defibrillator can save lives.

Weighing less than two pounds, the device consists of two main components: an electrode belt and garment that surround the patient’s chest, and a monitor that the patient wears around his or her waist. This device is intended only for children that weigh at least 41 pounds and have a chest size of 26 inches or more, about the size of an average 8 year old.

The device was first approved in 2001 for patients 18 years of age and older. Later models of the device were approved for patients 18 years of age and older in 2002, 2006 and 2009.

Today’s pediatric approval was based on published studies and a company registery containing clinical information from 248 patients, ages 3 to 17, at risk for sudden cardiac arrest. No additional safety concerns were identified, and four patients who experienced sudden cardiac arrest received a shock that successfully restored a life-sustaining heartbeat.

The LifeVest defibrillator is manufactured by the ZOLL Manufacturing Corporation based in Pittsburgh, Pennsylvania.

US Food and Drug Administration. FDA approves wearable defibrillator for children at risk for sudden cardiac arrest. Updated December 17, 2015.

Related Items
Once-Daily Injection Approved for Patients with Type 2 Diabetes
July 2016 - In the News published on July 29, 2016 in FDA Updates
First Oral Regimen FDA Approved for Treatment of Chronic HCV
June 2016 - In the News published on June 29, 2016 in FDA Updates
Nuplazid Approved for Psychosis-Associated Hallucinations in Patients with Parkinson’s Disease
May 2016 - In the News published on May 25, 2016 in FDA Updates
FDA Approves First Generic Version of Crestor for Multiple Indications in Adults
May 2016 - In the News published on May 25, 2016 in FDA Updates
FDA Enhances Warnings for Serious Risks of Opioid Analgesics Abuse
April 2016 - In the News published on April 26, 2016 in FDA Updates
Obiltoxaximab FDA-Approved to Treat and Prevent Inhalation Anthrax
March 2016 - In the News published on March 24, 2016 in FDA Updates
FDA Approves First Coagulation Factor-Albumin Fusion Protein to Treat Patients with Hemophilia B
March 2016 - In the News published on March 21, 2016 in FDA Updates
FDA Approves Briviact to Treat Partial Onset Seizures
March 2016 - In the News published on March 21, 2016 in FDA Updates
FDA Approves Integra Omnigraft Dermal Regeneration Matrix to Treat Diabetic Foot Ulcers
January 2016 - In the News published on January 12, 2016 in FDA Updates
FDA Approves Zurampic to Treat High Blood Uric Acid Levels Associated with Gout
January 2016 - In the News published on January 6, 2016 in FDA Updates
Last modified: January 6, 2016
  • American Health & Drug Benefits
  • The Journal of Hematology Oncology Pharmacy
  • Lynx CME
  • The Oncology Pharmacist

Search