About the Clinical Trials
The following abstracts describe the results of the multi-center clinical trial which led to FDA approval of the LifeVest.
The clinical trials, which spanned three years and 17 hospitals throughout the US and Europe, included 289 patients who wore the wearable defibrillator for a collective 873 months.
During the study, the LifeVest saved six lives. The most common adverse effect reported was a temporary skin rash, and incidents of false shocks were low(<2.3% per patient-month). The results confirmed that the LifeVest is a safe and effective alternative to emergency medical services (EMS).
New Therapeutic Option for Patients With Time-Dependent Risk of Sudden Cardiac Arrest: Application of Novel Wearable Cardioverter-Defibrillator
Abstract of presentation made by Dr. Arthur Feldman at American College of Cardiology Meeting on March 18, 2002, in Atlanta, Georgia
The Wearable Defibrillator - A New Method to Prevent Sudden Death
Ulf Meltendorf, MD, Anke Wollbrueck, RN, Angelo Auricchio, MD, Sven Reek, MD, Christoph J. Geller, MD, Helmut U. Klein, MD, University Hospital Magdeburg, Germany
Clinical Efficacy of the Wearable Defibrillator in Acutely Terminating Episodes of Ventricular Fibrillation Using Biphasic Shocks
Abstract of presentation made by Dr. Sven Reek at the North American Society of Pacing and Electrophysiology Conference on May 10, 2002, in San Diego, California