THE JEWEL® IDE STUDY

Pivotal study demonstrates the life-saving benefits of the Jewel® Patch Wearable Defibrillator (P-WCD).

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The Jewel® IDE Study

A clinical evaluation of the Jewel® Patch WCD in subjects at high risk for sudden cardiac arrest.

The Jewel® P-WCD is a safe and effective WCD that, due to its design, led to high patient compliance. Compared to traditional WCDs, in the Jewel® IDE Study, there were no deaths due to non-compliance as well as a high number of patient saves. 1


8

Successful conversions 1

1 Data on file

0

Deaths in the study population 1


Results

User Friendly Design Led to High Daily Protected Time 1

Jewel® patients had a median compliance of 97.8% (IQR: 86.1%,99.7%)

23.5

HRS

median daily protected time

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91.0% of patients wore the Jewel® for longer than the prespecified threshold of 14.1* hours per day

Mean protection time

Compliance bar graph

*Average daily protected time as reported in the VEST trial was 14.0 hours: J.E. Olgin, et al. NEJM (2018) 379:1205-1215, DOI: 10.1056/NEJMoa1800781​

1 Data on file

Powerful ML Algorithm Led to Low False Alarm Rate 1

Median false alarms: Jewel® 0 per month vs LifeVest 3 per month*

88.9

%

patients with <1 alarm per day

  • 61.7% of patients experienced 0 alarms / day
  • An additional 27.2% of patients experienced less than 1 alarms / day

* Kovacs B at al. J Clin Med 2021; 10:3811

1 Data on file

Effective Defibrillation Led to Successful Conversions and Numerous Lives Saved 1

8 successful conversions in 6 patients

6

LIVES

saved with 8 single conversions

Rhythm AdjudicationOutcome
1Polymorphic VT/VFReceived ICD
2Polymorphic VT/VFReceived CRT-D
3VTReceived ICD
4Pleomorphic VTReceived ICD
5*Coarse VFReceived ICD
5*Polymorphic VTReceived ICD
5*Coarse VF/Polymorphic VTReceived ICD
6Monomorphic VTReceived ICD

* One (1) patient experienced three (3) separate episodes of arrhythmia that were successfully converted

1 Data on file

Patient Save 1

Subject 132-007:

  • 75-year old male with ischemic cardiomyopathy (EF 30%)
  • Driving when he felt himself “passing out” and pulled off to the side of the road
  • Wife reported he was unresponsive but immediately gained consciousness after receiving a shock from the Jewel® P-WCD
  • Upon study exit, patient received an ICD

* Kovacs B at al. J Clin Med 2021; 10:3811

1 Data on file

Case study graph

A positive patient experience comes from putting people first.

Jewel® is a patch wearable defibrillator (P-WCD) intentionally designed to not get in the way of living. Being discreet, comfortable, and safe to shower with, the Jewel® delivers a completely new patient experience.

shot of an upper body wearing a Jewel defibrillator

Designed to be worn.

arrow pointing to the right
shot of a torso holding a phone

Designed to save lives.

Resources

Press Release:

Element Science Receives CE Mark & UKCA Mark for the Jewel Patch-Wearable Cardioverter Defibrillator

Press Release:

Successful Results of the Jewel® IDE Study Announcement

PDF cover page for  AHA presentation

AHA Presentation:

Get the presentation by John Hummel, MD, FACC

Thumbnail - Jewel Pivotal Study Patient Experience

Video:

Jewel Pivotal Study Patient Experience

Principal Investigators

Scientific Advisors