Zoll Medical said today it won FDA premarket approval for its Hospital Wearable Defibrillator.
The Chelmsford, Mass.-based company’s HWD is designed to continuously protect patients at risk of ventricular tachycardia or ventricular fibrillation during hospital stays. The wearable device is designed to automatically detect and treat such events.
“The HWD 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. It complements the tool kit the care team has in place for responding to cardiac arrest,” Zoll CEO Jonathan Rennert said in a prepared statement.
“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. David Shavelle of the University of Southern California said in a press release.
In December 2015, Zoll Medical won FDA premarket approval for its LifeVest wearable cardioverter defibrillator designed for children who are at risk for sudden cardiac arrest but aren’t candidates for an implantable defibrillator, according to an FDA release.
The LifeVest is the only wearable cardioverter defibrillator that monitors the heart continuously for abnormal heart arrhythmias and responds automatically, Zoll said.
The wearable device weighs less than 2 pounds and consists of an electrode belt and chest garment and a wrist-worn monitor. The LifeVest is intended for children that weigh at least 41 pounds with chest sizes of 26 inches or greater, which Zoll said is about the size of an average 8 year old.