Zoll Medical PMA Approved for Hospital Wearable Defibrillator

FDA has approved a Zoll Medical Corp. PMA for the Hospital Wearable Defibrillator (HWD). The device is 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,” the company says.

The HWD helps a care team manage at-risk patients by detecting VT and VF. “If a life-threatening rhythm is detected, the device alerts the patient prior to delivering a treatment shock, and thus allows a conscious patient to delay the treatment shock,” Zoll Medical says. The device is designed to deliver treatment within 60 seconds. It uses the same detection algorithm and defibrillation waveform as the company’s LifeVest Wearable Defibrillator. “Patients wearing the LifeVest have a 98% first shock success rate and 92% event survival rate,” it says.