Zoll gets FDA approval for in-hospital wearable defibrillator

By Jonah Comstock
02:25 pm

Medical device maker Zoll Medical Corporation has received FDA premarket approval for a wearable external defibrillator for use in the hospital. Zoll got approval last year for its LifeVest, a similar product designed for home use.

"The HWD [Hospital Wearable Defibrillator] offers hospital care teams a new option for managing patients at risk of VT/VF by providing continuous protection even outside of very expensive, high-acuity care areas,” Jonathan A. Rennert, CEO of ZOLL, said in a statement. “It complements the tool kit the care team has in place for responding to cardiac arrest.”

The system monitors the user's heart rhythm for signs of ventricular tachycardia or ventricular fibrillation. If it detects an irregularity, it performs a check to see if the wearer is conscious, giving them a chance to cancel the process if they are. If the wearer doesn't respond in a minute, the system delivers a shock. If the first shock doesn't return the heart rhythm to normal, it will administer another. 

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"The Hospital Wearable Defibrillator (HWD) utilizes the same detection algorithm and defibrillation waveform as the LifeVest wearable defibrillator, which is used for patients who are at risk for sudden cardiac death, including post-discharge patients," Zoll writes on its website. "Patients wearing the LifeVest have a 98 percent first treatment shock success rate and a 92 percent event survival rate (patients arriving conscious to the ER or remaining at home following their treatment event). The reason: timely intervention. Most patients are shocked within one minute. When the heart can be returned quickly to a perfusing rhythm, long-term complications can be minimized."


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