Jewel is a low-profile, water-resistant wearable cardioverter defibrillator designed to continuously monitor heart rhythm in order to detect and treat life-threatening arrhythmias in patients with a temporarily elevated risk for SCA. Photo: Business Wire.

Data from the Jewel IDE Study appear in the Journal of the American College of Cardiology (JACC)¹ and results the Jewel EP Lab Study, conducted in the European Union, are published in Europace.² “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,” Element Science Chief Medical Officer Dr. Zubin Eapen said. “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.”
 
Wearable cardioverter defibrillators (WCDs) 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 comfortably during daily activities, including showering and moderate exercise. The Jewel Wearable Patch Cardioverter Defibrillator is designed to integrate into patients’ lives, allowing them to comfortably carry out daily activities.
 
The Jewel IDE Study,¹ which enrolled 305 U.S. patients and successfully exceeded all pre-specified endpoints, provides crucial data on Jewel’s safety, compliance, and efficacy. Results show:

• High Compliance and Protected Time: Patients using Jewel achieved a median wear-time of more 23 hours daily, showcasing its ease of use and integration into patients’ everyday lives.
• Lives Saved and No Deaths: The device successfully converted eight separate ventricular tachycardia or ventricular fibrillation events in six different patients, effectively preventing SCA. No deaths occurred in study patients.
• Low Inappropriate Shock Rates: The study observed an inappropriate shock rate of 0.36 shocks per 100 patient-months. 

“The results are a clear indication that wearable defibrillators can be designed with the patient in mind. Jewel’s comfortable and water-resistant design allows patients to maintain their daily activities while still receiving life-saving protection,” state Dr. Javed Butler, a national principal investigator for the Jewel IDE Study and primary author.

The multicenter, prospective, single-arm Jewel IDE Study followed participants for up to 180 days in a primarily outpatient setting. The study evaluated the safety and effectiveness of the Jewel Patch Wearable Cardioverter Defibrillator in patients at high risk for sudden cardiac arrest. Endpoints included patient compliance/wear-time, number of patient saves/conversions, inappropriate shock rate, and cutaneous adverse device effects. The Jewel IDE Study successfully met its pre-defined endpoints.¹
 
“The study results presented in JACC represent a significant achievement for the company and provide clear evidence of how the high compliance seen with the Jewel led to patients wearing the device when they needed it, thereby saving numerous patients from SCA,” Element Science Founder, President, and CEO Dr. Uday N. Kumar commented. “Jewel’s design, accompanied by a sophisticated machine learning algorithm, addresses many of the challenges faced by traditional wearable defibrillators. We look forward to seeing the positive impact Jewel will have in real-world practice.”
 
In addition to the Jewel IDE Study, Element Science conducted the Jewel EP Lab Study² to provide the Jewel Patch’s foundational safety and effectiveness in terminating life-threatening arrhythmias. This first-in-human study, which also successfully met all pre-specified endpoints, confirmed that Jewel could successfully identify and convert life-threatening rhythms in a single shock. The EP Lab Study was a single-arm, open-label evaluation of the Jewel P-WCD defibrillation waveform in up to 18 adult cardiac patients while undergoing care in an EP (electrophysiology) lab setting. The study aimed to demonstrate Jewel’s clinical effectiveness in terminating life-threatening ventricular arrhythmias (VT/VF) with a single defibrillation shock. The EP Lab Study successfully met its pre-defined endpoint.²

“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,” Element Scientific Advisory Board member Dr. Karol Watson stated. “It’s a large step forward in providing effective solutions for those with significant heart disease.”
 
Jewel is a low-profile, water-resistant 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. The Jewel Mobile App enables timely patient care by transmitting therapy information to the patient’s medical team in near real-time.
 
Jewel is an investigational device and is limited by U.S. law to investigational use only. The product received CE Mark and UK Conformity Assessed (UKCA) marking, but is currently not commercially available in the European Union or Great Britain.
 
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 to address leading causes of death and hospitalization in patients with heart disease, primarily as they transition from the hospital to home. Its personalized digital devices are designed for function, comfort, and ease-of-use. Element Science’s first product, a wearable patch defibrillator, is initially targeted at treating more than 500,000 U.S. patients with an elevated temporary risk of potentially experiencing a lethal heart rhythm. Based in San Francisco, the firm’s investors include Third Rock Ventures, Google Ventures, Deerfield Management, Qiming Venture Partners USA, Cormorant Asset Management, and Invus Opportunities. 
 
References
¹ Jewel IDE Study Manuscript: JACC 84(6), p525-536: DOI 10.1016/j.jacc.2024.04.063  
Editorial: Patch Wearable Defibrillator: Excellent Therapy, But Patient Acceptance Is a Sticky Issue, JACC 84(6) p537-539: DOI 10.1016/j.jacc.2024.06.014
² EP Lab Study Manuscript: EP Europace 26(7), e189: DOI 10.1093/europace/euae189 

Article source: Medical Product Outsourcing