EU, British Regulators OK Wearable Cardioverter Defibrillator

Element Science has received the European Union’s CE mark certification and Great Britain’s UK Conformity Assessed (UKCA) marking for its Patch Wearable Cardioverter Defibrillator (P-WCD).

“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,” Element Science Founder/President/CEO Dr. Uday N. Kumar said. “Gaining the CE mark under the European Union Medical Device Regulation as well as the UKCA mark are testaments to the strength of the development, testing, and clinical results of the Jewel P-WCD.”
 
The Jewel P-WCD is 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 Jewel defibrillator’s efficacy has been confirmed through 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.
 
“Element Science is leveraging advancements in machine learning, wearable technologies, and miniaturization to revolutionize the way patients receive care. Based on my 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,” said Hank Kucheman, a former CEO of Boston Scientific and currently the non-executive chairman and member of Element Science’s Board of Directors. “The company is now well-positioned to plan for delivering this lifesaving technology to patients outside the U.S.”
 
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. The water resistant wearable defibrillator is designed to detect and treat life-threatening arrhythmias in patients with a temporarily elevated risk for SCA. The device continuously monitors a patient’s heart and treats specific life-threatening rhythms. It is designed for continued protection during normal daily activities, including showering, sleeping, and moderate exercise. The Jewel Mobile App enables timely patient care by transmitting therapy information to the patient’s medical team in near real-time.
 
The Jewel IDE Study was a multicenter, prospective, single-arm study that enrolled 305 patients for up to 180 days. The study objective was to evaluate the safety and effectiveness of the Jewel P-WCD in patients at high risk for sudden cardiac arrest. Endpoints included: patient compliance / wear-time, number of patient saves / conversions, arrhythmia detection, therapy effectiveness, inappropriate shock rate, and cutaneous adverse device effects. 
 
Element Science Inc. is a medical device and digital health company developing solutions at the intersection of clinical-grade wearables, machine learning algorithms, and lifesaving therapies that address the causes of heart disease-related death and hospitalization, primarily as they transition from the hospital-to-home. By putting the needs of patients and physicians first, the company’s personalized digital devices—designed for function, comfort, and ease-of-use—aim to redefine the paradigm of care for these patients. Its first product, a wearable patch defibrillator, is initially targeted at treating more than 500,000 patients in the United States and Europe with an elevated temporary risk of potentially experiencing a lethal heart rhythm. Based in San Francisco, its funders include Third Rock Ventures, Google Ventures, Deerfield Management, Qiming Venture Partners USA, Cormorant Asset Management, and Invus Opportunities.