Element Science, an innovative health technology company pioneering a digital wearable platform for high-risk cardiovascular patients, announced that it has received the European Union’s CE mark certification and Great Britain’s UK Conformity Assessed (UKCA) marking for its novel Patch Wearable Cardioverter Defibrillator (P-WCD) from its Notified Body, the BSI Group.
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The Jewel P-WCD was designed to address limitations with traditional garment-based WCDs. While these garment-based WCDs have demonstrated the ability to treat sudden cardiac arrest (SCA), a leading cause of death in the United States and in Europe, challenges related to patient comfort and compliance have resulted in avoidable deaths and limited their widespread adoption.
The effectiveness of the Jewel defibrillator was confirmed in the Jewel EP Lab Study, conducted in Prague, Czech Republic, 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 presented at the American Heart Association’s 2023 Annual Scientific Sessions 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.
Dr. Uday N. Kumar, Founder, President & CEO of Element Science commented, “Out-of-hospital SCA remains a significant problem in the United States and Europe with approximately only about 10% of patients surviving. 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.”
Hank Kucheman, who previously served as the CEO of Boston Scientific and is the non-executive chairman and long-time member of the Element Science Board of Directors, said, “Element Science is on the leading edge of leveraging advancements in machine learning, wearable technologies, and miniaturization to revolutionize the way patients receive care. Based on my long experience in medical technology development, the rigor of the approach with which the Jewel P-WCD was designed and tested has been validated by these approvals. The company is now well positioned to plan for delivering this lifesaving technology to patients outside the US.”
Dr. Petr Neužil, the Head of Cardiology and director of Cardiac Arrhythmia Service at Na Homolce Hospital in Prague, Czech Republic and lead investigator in the Jewel EP Lab Study, added “This novel approach to medical device design has created an exceptional patient experience and advantages that are likely to expand the use of WCDs to many more patients. I look forward to one day being able to prescribe the Jewel to my patients.”
In Europe, of the approximately 300,000 individuals experiencing OHCA annually, only about 8-10% survive. 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, addressing an important public health issue in Europe.
The Jewel P-WCD is limited to investigational use only and is not available for sale in the United States.
