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Patch Wearable Cardioverter-Defibrillator found Safe and Effective for Patients at Risk of Sudden Cardiac Arrest

By HospiMedica International staff writers
Posted on 07 Aug 2024
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Image: The Jewel patch-wearable cardioverter defibrillator is a first of its kind life-saving technology that has received the CE Mark and UKCA Mark (Photo courtesy of Element Science)
Image: The Jewel patch-wearable cardioverter defibrillator is a first of its kind life-saving technology that has received the CE Mark and UKCA Mark (Photo courtesy of Element Science)

Sudden cardiac arrest (SCA) outside of hospital settings continues to pose a major challenge in the United States and Europe, with survival rates hovering around 10%. While traditional wearable cardioverter defibrillators (WCDs) have proven effective in treating SCA, one of the leading causes of death in these regions, issues such as discomfort and lack of patient adherence have hindered their broad acceptance and contributed to preventable fatalities. Now, a new study has demonstrated the safety and efficacy of a new type of device, a water-resistant patch–wearable cardioverter-defibrillator (P-WCD), which incorporates a machine learning algorithm to enhance patient compliance and protection against SCA.

Element Science’s (San Francisco, CA, USA) Jewel P-WCD is a cutting-edge, water-resistant wearable defibrillator that detects and treats life-threatening arrhythmias in patients at temporary high risk for SCA. This device monitors the heart continuously and intervenes during critical arrhythmias. It is designed to offer consistent protection throughout daily activities, including showering, sleeping, and engaging in moderate exercise. The associated Jewel Mobile App supports efficient patient management by sending therapy data to healthcare providers almost instantaneously. The design of the Jewel P-WCD focuses on improving user compliance, which has been clinically demonstrated to enhance the chances of delivering lifesaving therapy when needed, thus potentially increasing survival rates from out-of-hospital SCA—a significant public health concern in Europe.

The Jewel IDE Study, a prospective, single-arm study carried out across 30 U.S. sites, involved participants at risk of SCA due to ventricular tachycardia or ventricular fibrillation who were either ineligible for or declined an implantable defibrillator. The findings published in Journal of the American College of Cardiology indicate that the novel P-WCD, an adhesive-based wearable defibrillator, achieved its primary and secondary safety and effectiveness targets with no fatalities attributed to noncompliance. These findings suggest that the P-WCD could serve as an effective alternative for patients recommended for WCD therapy.

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