Successful Study Confirms Effectiveness of Jewel Wearable Defibrillator

In a recent study, the Jewel wearable cardioverter defibrillator has demonstrated its capability to effectively prevent sudden cardiac arrest (SCA) in patients. The study, involving 305 participants, exceeded all pre-specified endpoints and was published in the Journal of the American College of Cardiology (JACC).

Dr. Zubin Eapen, Chief Medical Officer of Element Science, emphasized the high risk faced by patients with significant heart disease, particularly post-heart attack. The Jewel device offers continuous SCA protection, enabling patients to recover at home while significantly improving their chances of survival.

The Jewel wearable defibrillator addresses challenges related to patient comfort and compliance, which have historically limited the adoption of wearable cardioverter defibrillators. Its low-profile and water-resistant design allows for comfortable wear during daily activities, including showering and moderate exercise.

The Jewel IDE Study, which successfully met its endpoints, revealed crucial data about the safety, compliance, and efficacy of the Jewel Patch Wearable Cardioverter Defibrillator. Results showed a marked increase in patient compliance and the effective restoration of normal heart rhythms.

Dr. Javed Butler, a national principal investigator for the Jewel IDE Study, noted that the Jewel’s design prioritizes patient comfort, which allows individuals to maintain daily activities while receiving life-saving treatment. The study followed participants for up to 180 days and evaluated multiple endpoints, including compliance and inappropriate shock rates.

Element Science’s Founder, President, and CEO, Dr. Uday N. Kumar, stated that the high compliance rates associated with Jewel led to successful interventions during critical moments, saving numerous patients from SCA. The company looks forward to the positive impact Jewel will have in practical medical settings.

In conjunction with the Jewel IDE Study, Element Science conducted the Jewel EP Lab Study to validate the device’s foundational safety and effectiveness in terminating life-threatening arrhythmias. This initial study confirmed that Jewel could accurately identify and convert dangerous heart rhythms with a single shock.

Dr. Karol Watson, a member of Element Science’s Scientific Advisory Board, highlighted that improved adherence to wearable defibrillators is crucial for enhancing patient outcomes. Both the EP Lab Study and the Jewel IDE Study underscore Jewel’s potential to offer continuous heart protection without compromising comfort and adherence.

The Jewel device is designated for investigational use and has received UKCA marking, but it is not yet available for commercial use in the European Union or Great Britain.