Element Science has concluded patient recruitment for its Jewel investigational device exemption (IDE) study, which is designed to assess the Jewel Patch Wearable Cardioverter Defibrillator (P-WCD).
The trial aims to assess the safety and effectiveness of the Jewel P-WCD in monitoring heart rhythms and providing defibrillation treatment.
Results from the IDE study will be used to obtain regulatory approval in the US for the Jewel P-WCD.
Element Science chief medical officer Dr Zubin Eapen said: “We are grateful to the study participants and clinical research professionals for their commitment and contributions to the Jewel IDE Study.
“Completing enrolment is an important milestone toward reaching our goal of changing the paradigm of treatment for cardiovascular patients so they can safely return to their normal daily lives without fear or discomfort.”
The Jewel P-WCD is a low-profile wearable defibrillator designed to identify and treat arrhythmias in individuals who face a temporarily increased risk of sudden cardiac arrest.
The device continuously monitors the heart of the patient for the treatment of specific life-threatening rhythms. It provides continued protection during regular daily routines, encompassing activities such as moderate exercise, sleeping and showering.
By delivering information related to therapy to the patient’s medical care team in near real-time, the Jewel Mobile App facilitates timely patient care.
A patient case from the Jewel IDE study was presented at the Heart Rhythm 2023 event in New Orleans, Louisiana, US, highlighted the advantages of utilising the Jewel P-WCD and the associated mobile app.
Shortly after onset, the Jewel P-WCD demonstrated its capability in identifying and converting a life-threatening rhythm exhibited by the patient.
The Jewel Mobile App offered emergency caregivers access to vital diagnostic information, enabling them to quickly and precisely triage patients upon their arrival at the emergency department.