Element Science 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.
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.
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.