Digital health company Element Science has announced that positive data from the Jewel IDE study of its patch-based wearable defibrillator has been published.
The Jewel IDE study (NCT05201495), published in the Journal of the American College of Cardiology (JACC), met all pre-specified endpoints. Of the 305 enrolled patients, a high level of compliance was observed, with a median wear time of over 23 hours per day.
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The device effectively managed cardiac events, successfully converting eight incidents of ventricular tachycardia or ventricular fibrillation in six patients, with no deaths reported during the study period. Additionally, the rate of inappropriate shocks was low, at 0.36 shocks per 100 patient-months.
The Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) is a water-resistant wearable defibrillator designed to detect and treat severe arrhythmias in patients at temporarily elevated risk of sudden cardiac arrest (SCA). It addresses the limitations associated with traditional garment based WCDs, where challenges related to patient comfort and compliance resulted in avoidable deaths.
The device continuously monitors the heart of the patient for the treatment of specific life-threatening rhythms. It provides continued protection during regular daily routines, encompassing activities such as moderate exercise, sleeping and showering. The device comes with the Jewel Mobile App, which transmits therapy information to the patient’s medical team in near real-time to enable timely patient care.
Although the Jewel P-WCD is not approved in the US, it secured CE and UKCA marks in January 2024 based on data from this study, as well as the Jewel EP Lab study. Conducted in Prague, Czech Republic, the system successfully restored normal heart rhythm in 16 patients experiencing ventricular arrhythmias with a single therapeutic shock.
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By GlobalDataElement Science’s CEO Uday Kumar said: “The study results presented in JACC represent a significant achievement for the company and provide clear evidence of how the high compliance seen with the Jewel led to patients wearing the device when they needed it, thereby saving numerous patients from SCA.
“Jewel’s unique design, accompanied by a sophisticated machine learning algorithm, addresses many of the challenges faced by traditional wearable defibrillators. We look forward to seeing the positive impact Jewel will have in real-world practice.”
In March 2020, the US company raised $145.6m through a Series C funding round to boost its next generation digital wearable platform. Element’s Jewel platform combines patient-centric human factor engineering and machine learning algorithm development principles on a basis of electromechanical medical device development standards. The Jewel P-WCD is the first product to be developed on the platform.
According to GlobalData, the wearable tech industry is forecast to generate $290.6bn by 2030.
GlobalData is the parent company of Clinical Trials Arena.
