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Wearable Cardioverter Defibrillator Protects Patients at High Risk of Sudden Cardiac Arrest

By HospiMedica International staff writers
Posted on 30 Jan 2024
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Image: The Jewel Patch-Wearable Cardioverter Defibrillator has received the CE Mark and UKCA Mark (Photo courtesy of Element Science)
Image: The Jewel Patch-Wearable Cardioverter Defibrillator has received the CE Mark and UKCA Mark (Photo courtesy of Element Science)

Sudden cardiac arrest (SCA) is a leading cause of death in the United States and in Europe where out-of-hospital SCA remains a significant problem with approximately only about 10% of patients surviving. Traditional garment-based Wearable Cardioverter Defibrillators (WCDs) have demonstrated the ability to treat SCA, although challenges related to patient comfort and compliance have resulted in avoidable deaths and limited their widespread adoption. Now, a novel wearable patch defibrillator is designed to address the limitations with garment-based WCDs, paving the way for enhanced protection of patients with elevated risk of SCA.

The Jewel P-WCD (Patch-WCD) from Element Science (San Francisco, CA, USA) is a revolutionary wearable patch defibrillator that offers a new level of protection and peace of mind for those at risk of SCA. It can detect and treat specific life-threatening rhythms as soon as they happen, and offers dependable protection with nearly continuous wear-time compliance. Its discreet under-clothing design and sleek wearable technology allows it to be taken anywhere while allowing clinicians to engage with their patient’s care using the company’s streamlined, easy-to-use digital platform. The device is also compatible with daily activities like showering and moderate exercise.

The Jewel P-WCD, developed with a design focused on enabling better compliance that has been clinically shown to lead to the delivery of lifesaving therapy when required, may significantly increase the chances of survival in OHCA. The effectiveness of the Jewel defibrillator was confirmed in the Jewel EP Lab Study, in which 16 patients experiencing ventricular arrhythmias were successfully converted to a normal heart rhythm after a single therapeutic shock. The Jewel IDE Study, a pivotal study of 305 patients, demonstrated significant patient compliance and protected time resulting in a high number of successful patient saves and no deaths or serious adverse events related to the device. Element Science has now received the European Union’s CE mark certification and Great Britain’s UK Conformity Assessed (UKCA) marking for its novel P-WCD from its Notified Body, the BSI Group.

"Out-of-hospital SCA remains a significant problem in the United States and Europe with approximately only about 10% of patients surviving,” said Dr. Uday N. Kumar, Founder, President & CEO of Element Science. “The Jewel was developed to address the compliance issues of garment-based WCDs by focusing on user experience design and by incorporating advanced machine learning algorithms, both of which are approaches common in consumer wearables but relatively uncommon in medical device development. Gaining the CE mark under the rigorous European Union Medical Device Regulation (EU MDR) as well as the UKCA mark are testaments to the strength of the development, testing, and clinical results of the Jewel P-WCD.”

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