Element Science has reported positive results from two studies evaluating its Jewel patch wearable cardioverter defibrillator (P-WCD) for patients at risk of sudden cardiac arrest (SCA).
The Jewel P-WCD is a water-resistant wearable cardioverter defibrillator that continuously monitors a patient’s heart rhythm to detect and treat life-threatening arrhythmias, particularly in those with a temporarily elevated risk of SCA.
It is said to offer round-the-clock protection, even during everyday activities such as showering, sleeping, and moderate exercise. The associated Jewel mobile app delivers real-time therapy updates to the patient’s medical team, ensuring prompt and effective management of the patient’s condition.
In the US, the device is limited to investigational use only.
Earlier this year, Jewel P-WCD secured CE Mark and UK Conformity Assessed (UKCA) marking. However, it is yet to be commercially available in the European Union or the UK.
Element Science, which is based in San Francisco, is a health technology firm specialising in digital wearables for high-risk cardiovascular patients.
The company assessed Jewel P-WCD in the Jewel IDE study and Jewel EP Lab trial.
The Jewel investigational device exception (IDE) study registered 305 patients and surpassed all pre-specified endpoints, demonstrating the cardioverter defibrillator’s safety, compliance, and effectiveness.
In August 2022, the company announced the first patient save with the Jewel device in the IDE study.
Individuals using the defibrillator achieved a median wear-time of more than 23 hours daily.
The device converted eight instances of ventricular tachycardia or ventricular fibrillation in six patients. This prevented SCA, with no deaths reported during the study.
Additionally, the study observed a low inappropriate shock rate of just 0.36 shocks per 100 patient-months.
Furthermore, the Jewel EP Lab Study was conducted to establish the foundational safety and effectiveness of the Jewel in terminating arrhythmias.
It enrolled up to 18 adult cardiac patients while undergoing care in an electrophysiology (EP) lab setting.
The first-in-human study, which also met all pre-defined endpoints, demonstrated that the Jewel P-WCD could identify and convert life-threatening rhythms successfully with a single shock.
Element Science founder, president, and 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.”
