In a new study, the investigational device converted eight ventricular tachycardia or ventricular fibrillation events in six patients, and there were no deaths.


Summary: Element Science announced positive results from its Jewel IDE study in the US and Jewel EP Lab study in the EU, highlighting the efficacy and benefits of the Jewel Patch wearable cardioverter defibrillator for patients at risk of sudden cardiac arrest (SCA). The studies, published in prestigious journals, demonstrate high safety, compliance, and effectiveness of the Jewel device, which addresses previous challenges in patient comfort and adherence with its low-profile, water-resistant design.

Key Takeaways:

  1. Study Results: The Jewel IDE and Jewel EP Lab studies demonstrated high safety, compliance, and efficacy for the Jewel Patch Wearable Cardioverter Defibrillator in preventing sudden cardiac arrest.
  2. Patient Compliance: The low-profile, water-resistant design of the Jewel device addresses comfort and adherence issues, allowing patients to wear it continuously during daily activities.
  3. Clinical Validation: Both studies exceeded pre-specified endpoints, with the Jewel IDE study showing a median wear-time of over 23 hours per day and successful conversion of life-threatening arrhythmias with a low inappropriate shock rate.

Health technology company Element Science announced the publication of positive results from its Jewel IDE study, conducted in the United States, and the Jewel EP Lab study, conducted in the European Union, demonstrating the benefits of the Jewel Patch wearable cardioverter defibrillator for patients at risk of sudden cardiac arrest (SCA).

Results of the Jewel IDE study were published in the Journal of the American College of Cardiology, and results of the Jewel EP Lab study were published in EP Europace

“Patients with significant heart disease, especially those who are recovering from certain events like a heart attack, face a high frequency of out-of-hospital SCA, often accompanied by a low survival rate,” says Zubin Eapen, MD, Element Science’s chief medical officer, in a release. “By enabling truly continuous SCA protection that patients can easily manage while they recover at home, Jewel can greatly enhance these patients’ survival prospects and is an important addition to the tools physicians have to protect their patients.”

Addressing Compliance Issues

Wearable cardioverter defibrillators are effective at restoring patient’s heart rhythms to a normal rhythm, but they have faced challenges related to patient comfort and, therefore, compliance, limiting their widespread adoption and leading to potentially avoidable deaths from SCA. 

Jewel addresses these compliance issues with its low-profile, water-resistant design, allowing patients to wear the device during daily activities, including showering and moderate exercise. 

The Jewel IDE study, which enrolled 305 patients and exceeded all pre-specified endpoints, provides data on Jewel’s safety, compliance, and efficacy.

  • Patients using Jewel achieved a median wear-time of over 23 hours per days.
  • The device successfully converted eight separate ventricular tachycardia or ventricular fibrillation events in six different patients, effectively preventing SCA. No deaths were observed in patients while enrolled in the study.
  • The study observed a very low inappropriate shock rate of just 0.36 shocks per 100 patient-months.

Clinical Validation and Study Findings

In addition to the Jewel IDE study, the Jewel EP Lab study was conducted to provide foundational safety and effectiveness of the Jewel in terminating life-threatening arrhythmias. 

This first-in-human study, which also met all pre-specified endpoints, was crucial as it confirmed that Jewel could successfully identify and convert life-threatening rhythms in a single shock, according to a release from Element Science.

“Improved adherence with wearable defibrillators can significantly impact patient outcomes. Results from the EP Lab study followed by the Jewel IDE study showcase the potential of the Jewel P-WCD to provide continuous protection for patients at risk of SCA, without the usual challenges related to comfort and adherence. It’s a large step forward in providing effective solutions for those with significant heart disease,” says Karol Watson, a member of Element Science’s scientific advisory board, in a release.

Market Availability and Regulatory Status

Jewel is an investigational device and is limited by US law to investigational use only. It is not available for sale in the US. Jewel received CE Mark and UK Conformity Assessed (UKCA) marking in January 2024 but is currently not commercially available in the European Union or Great Britain.

Photo caption: Jewel is a wearable cardioverter defibrillator designed to continuously monitor a patient’s heart rhythm in order to detect and treat life-threatening arrhythmias in patients with a temporarily elevated risk for SCA. It is designed for 24/7 protection, including during normal daily activities like showering, sleeping, and moderate exercise.

Photo credit: Business Wire