FDA grants premarket approval for Hospital Wearable Defibrillator from Zoll Medical/Asahi Kasei.
ZOLL Medical Corporation, an Asahi Kasei Group Company that manufactures medical devices and related software solutions, announced that the company�s Hospital Wearable Defibrillator (HWD) has been granted premarket approval (PMA) by the FDA to market and begin U.S. distribution of the device.
The ZOLL HWD is specifically designed to continuously protect patients at risk of ventricular tachycardia or ventricular fibrillation (VT/VF) during their stay in the hospital. For a patient experiencing VT/VF, each minute that defibrillation is delayed increases the likelihood of dying or the likelihood of surviving with complications. Through automatic detection and immediate treatment, the ZOLL HWD provides patients at risk for VT/VF with continuous protection anytime day or night in the hospital. The HWD is an innovative tool for hospital care teams to manage patients at risk of VT/VF. Automatic detection and immediate treatment address the most critical factor for survival from cardiac arrest in these patients�timely defibrillation.
Comment:ZOLL indicates that the Hospital Wearable Defibrillator uses the same arrhythmia detection technology and shock delivery as its LifeVest Wearable Defibrillator, which when studied demonstrated a 98% first shock success rate and a 92% event survival rate.