After securing approvals in the U.K. and Europe early last year, Element Science has now claimed a green light from the FDA for its wearable defibrillator patch, offering a non-invasive option for patients facing a temporarily elevated risk of sudden cardiac arrest.
That includes people who may be recovering from a heart attack or have other significant cardiovascular disease. The Jewel wearable cardioverter defibrillator system can be worn during sleep and showers, with its low-profile and water-resistant design. It includes a reusable defibrillator unit and battery pack, plus two single-use electrode skin patches that are replaced once a week.
“The Jewel Patch-WCD is the culmination of a vision to give patients a life-saving device that seamlessly integrates into their daily lives,” Element Science President and CEO Uday Kumar said in a statement. “FDA approval represents more than a regulatory milestone; it’s a leap forward in how we, as clinicians, think about using cutting-edge therapeutic technology to empower patients to live their fullest lives, even when at risk of sudden cardiac arrest.”
Last year, Element put forward clinical data from a U.S. pivotal trial of about 300 people, which clocked a median wear-time of more than 23 hours per day. The device successfully detected and delivered corrective shocks in eight separate cases of ventricular tachycardia or fibrillation among six patients, with all potentially dangerous heart rhythms being converted with the first shock.
The company said no deaths or serious complications were observed while participants were enrolled. It reported its first real-world patient save of the study in August 2022, with a person in a rural area far from first responders, who had a life-threatening arrhythmia within a week after returning home from a hospital.
In terms of false-positive alerts, Element said Jewel recorded 0.357 inappropriate shocks per 100 patient-months. The results were published in the Journal of the American College of Cardiology.
The San Francisco-based Element previously raised $145 million in venture capital funding through a March 2020 series C round, led by Deerfield Healthcare and Qiming Venture Partners USA, and backed by Cormorant Asset Management, Invus Opportunities, Third Rock Ventures and Google Ventures.