FDA Approves Zoll Medical's Hospital Wearable Defibrillator

March 9, 2017—Zoll Medical Corporation, an Asahi Kasei Group Company, announced that the company’s hospital wearable defibrillator (HWD) has been granted premarket approval by the US Food and Drug Administration (FDA) to begin marketing the device in the United States.

The Zoll HWD is designed to continuously protect patients at risk of ventricular tachycardia (VT) or ventricular fibrillation (VF) during hospital stays. The HWD utilizes the same detection algorithm and defibrillation waveform as Zoll's LifeVest wearable defibrillator. Published studies have shown that patients wearing the LifeVest have a 98% first shock success rate and 92% event survival rate, noted the company.

According to Zoll Medical, the HWD allows for automatic detection and immediate treatment to provide patients at risk for VT/VF with continuous protection at any time in the hospital, thereby addressing the most critical factor for survival from cardiac arrest in these patients—timely defibrillation. If a life-threatening rhythm is detected, the device alerts the patient before delivering a treatment shock, allowing a conscious patient to delay the treatment shock. The device is designed to deliver treatment within 60 seconds.

In the company's press release, David M. Shavelle, MD, commented, “The ability to provide hospitalized patients at risk for malignant ventricular arrhythmias a safe and effective device that enables rapid defibrillation represents a significant improvement in the care of cardiovascular patients.” Dr. Shavelle is Associate Clinical Professor at Keck School of Medicine Division of Cardiology at the University of Southern California (USC) in Los Angles, California, Director of the Los Angeles County USC Cardiac Catheterization Laboratory, and Director of the General Cardiology Fellowship Program at USC.