Technological innovation in healthcare continues to demonstrate its positive impact on patient care. Implicity, an agnostic remote cardiac monitoring platform, conducted a large-scale retrospective study, EVIDENCE-RM¹, to assess the benefits of its platform in real-life conditions for managing CIED patients.
A robust study based on real world data
Implicity used patient data from the French National Health Data System (SNDS) and its own database to conduct the study. The study sample included 38,687 patients with implantable cardiac defibrillators (ICDs) and data was analyzed to assess the clinical and medico-economic impact of Implicity’s remote monitoring platform compared to the standard of care using manufacturer’s web portals.
Study results: clinically proven effectiveness
The study demonstrated the significant benefits of the IMPLICITY IM009² remote cardiac monitoring solution compared to the standard of care using manufacturer’s web portals:
- a 26% reduction in the all-cause mortality rate
- a 2% reduction in all cause hospital admissions
- a 4% reduction in the length of all cause hospitalization stays
A major step forward for patients and the healthcare system
The study results confirmed Implicity’s contribution to improving the quality of patient care and management of patients with ICDs. By reducing all cause mortality and hospitalizations, the platform contributes to better patient care and lowers costs for the healthcare system.
Major recognition from the French National Authority for Health
The impact of the EVIDENCE-RM study results was recognized by the French National Authority for Health (HAS) to issue a favorable opinion on the registration of Implicity as a brand name for remote cardiac monitoring of CIED patients. The HAS decision was based on the superiority of the Implicity platform to improve the quality of patient care and lower healthcare system costs for CIED patients. Following the independent validation by HAS, Implicity has taken a decisive step towards wider adoption of its platform by healthcare systems for the benefit of patients and healthcare providers.
¹N. Varma et al., “Impact of a universal monitoring system (‘third party’) on outcomes of ICD patients: A nationwide study,” Heart Rhythm, 2024.
²IM009: 2021. Manufacturer: Implicity. IM009 is a software as a medical device (SaMD) intended to be used as an adjunct of a remote monitoring platform to follow-up target population patients. IM009 is compatible with devices with remote monitoring feature such as cardiac implantable electronic devices and connected weight scales. The three main intents of IM009 are to (1) label observations generated by medical devices according to predefined categories, (2) create clinically relevant observations for worsening atrial fibrillation and/or rapid weight gain in the context of heart failure, based on data recorded by the device and (3) label Atrial Fibrillation burden observations generated by cardiac implantable electronic device (CIED) as to be hidden or relevant for health care provider based on patient’s anticoagulation status. Hence, IM009 is designed to reduce the workload burden of healthcare providers/professionals in charge of reviewing the observations received from the patients’ devices. IM009 is not intended for use in life supporting or sustaining systems or Alarm devices and as a solely means of diagnosis. It is offered to healthcare providers/professionals on an advisory basis only in conjunction with the physician’s knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information. Class I, according to Medical Device Directive 93/42/EEC. See the instructions for use for more information. Covered under the conditions defined in Article L. 162-52 of the French Social Security Code.