Element Science announced positive data from a study of its Jewel patch-wearable cardioverter defibrillator (P-WCD).
The FDA investigational device exemption evaluated Jewel for sudden cardiac arrest (SCA) prevention across 305 patients.
San Francisco-based Element Science developed Jewel with patient experience in mind, creating a low-profile, lightweight design. The water-resistant device allows patients to comfortably wear Jewel during daily activities like showering and exercising.
A proprietary machine learning algorithm powers Jewel, which accurately detects abnormal heart rhythms. This results in a low false alarm rate and timely defibrillation when needed, according to a news release.
The low-profile device continuously monitors the heart and treats life-threatening rhythms. Its accompanying Jewel mobile app enables timely care by transmitting therapy information to the patient’s medical team in near real-time.
“From the outset, our goal has been to improve the outcomes of patients who have a temporary risk of experiencing sudden cardiac arrest by creating a solution based on the realities of patients’ lives,” said Dr. Uday N. Kumar, founder, president and CEO of Element Science. “The findings from the study demonstrate that a diverse group of patients, from a wide variety of geographies and climates, can achieve high wear-time compliance with the Jewel P-WCD, translating into extended protection from SCA and the best opportunity for a favorable outcome in their daily lives.”
Key findings from the Element Science study
Dr. John Hummel presented findings from the Jewel IDE study at the American Heart Association’s 2023 Annual Scientific Sessions. Results demonstrated the safety and efficacy of the Jewel P-WCD.
Element Science saw no deaths or serious adverse events related to the device and reported high compliance and protected time. Patients wearing the Jewel device achieved a median wear-time of more than 23 hours per day. The company says this showcases its ease of use and integration into daily life.
Jewel also successfully converted eight separate ventricular tachycardia or ventricular fibrillation events in six patients. All were successfully saved thanks to the conversions.
The study also showed low false alarms and inappropriate shock rates, with just 0.36 shocks per 100 patient months. Element Science said this offers patients peace of mind and reduces inconveniences associated with false alarms.
“The results of the Jewel IDE Study are extremely encouraging,” Hummel said. “No currently available technology appears to provide the level of protection and compliance we saw in this study, indicating the true value of patient-centric innovation for those at risk of sudden cardiac arrest.”