Implicity's EVIDENCE-RM Study Demonstrates Marked Improvement in ICD Patient Outcomes
Comprehensive analysis of real-world data shows significant clinical and medico-economic advantages of Implicity's universal, alert-based remote monitoring platform
CAMBRIDGE, Mass., April 24, 2025 /PRNewswire/ -- IMPLICITY®, a leader in remote patient monitoring and cardiac data management solutions, today unveiled new findings from its EVIDENCE-RM study¹. Leveraging extensive data from the French National Health Data System (SNDS), the study demonstrated clear clinical and medico-economic benefits associated with Implicity's universal monitoring system (UMS) compared to conventional, manufacturer-specific systems, including Abbott, Biotronik, Boston Scientific, and Medtronic.
The study, recently published in Heart Rhythm, analyzed clinical outcomes and costs for over 69,000 patients with implantable cardioverter-defibrillators (ICDs) and defibrillators with cardiac resynchronization therapy (CRT-Ds). Patients remotely monitored using Implicity's platform showed increased survival rates and a reduction in both the number and duration of all-cause and heart failure-related hospitalizations, resulting in substantial healthcare cost reductions. Key findings attributed to Implicity's IM009² platform include:
- 26% reduction in mortality (HR, 0.74; 95% CI, 0.73–0.77; P=.001)
- 4% decrease in HF hospitalizations, total corrected healthcare costs, and mean duration of hospitalization
- 17.8% decrease in hospital-related costs, primarily driven by decreased costs in cardiovascular disease care
- Incremental Cost-Effectiveness Ratio (ICER) of approximately -$112 USD (-103€) per Day Alive and Out of Hospital (DAOH) based on the French Healthcare System
"Managing patients with ICDs and CRTs presents considerable challenges, since they are at high risk of hospitalization due to arrhythmias and heart failure," said Dr. Niraj Varma, Professor of Medicine and Director, Cardiac Pacing & Tachyarrhythmia Devices at the Cleveland Clinic. "The EVIDENCE-RM study clearly demonstrates that a universal monitoring solution operating alert-based remote monitoring can significantly reduce these risks, improving patient outcomes and substantially lowering healthcare costs. This is an important advancement in our ability to proactively manage patients with ICDs and CRTs."
"These findings mark a pivotal moment in remote cardiac care and prove Implicity's effectiveness with unparalleled clinical results," stated Implicity CEO Dr. Arnaud Rosier. "A 26% reduction in mortality and better use of healthcare resources highlight the impact of universal remote monitoring, driven by AI, over fragmented manufacturer-specific systems. Implicity is committed to driving innovation so that every cardiac patient receives proactive, efficient care."
For more information about Implicity and the EVIDENCE-RM study, please visit www.implicity.com.
About Implicity
Implicity is a digital MedTech software company dedicated to providing the best remote care to patients with cardiac implantable electronic devices and heart failure. Co-founded by cardiac electrophysiologist Arnaud Rosier, MD, PhD, the platform aggregates, normalizes, and standardizes data from any implantable cardiac device across all manufacturers, improving care for patients with cardiac implants and heart failure.
Implicity's platform provides critical health information augmented by FDA-cleared AI³ algorithms, enabling healthcare providers to make more informed decisions for better patient outcomes. With access to the Health Data Hub, one of the world's largest databases of heart disease patients, Implicity is able to develop its AI solutions based on more robust data. The company is protecting more than 100,000 patients in over 200 medical facilities across the US and Europe. To learn more, visit www.implicity.com
Health Data Hub is a health data platform established by the French government to combine existing health patient databases and facilitate their usage for research and development purposes
References
SignalHF FDA cleared Class II medical device and CE marked Class IIa (under MDR) medical device. Manufacturer: Implicity. The SignalHF System is intended for use by qualified healthcare professionals (HCP) managing patients over 18 years old who are receiving physiological monitoring for Heart Failure surveillance and implanted with a compatible Cardiac Implantable Electronic Devices (CIED) (i.e., compatible pacemakers, ICDs, and CRTs). The SignalHF System provides additive information to use in conjunction with standard clinical evaluation. The SignalHF HF Score is intended to calculate the risk of HF for a patient in the next 30 days. This System is intended for adjunctive use with other physiological vital signs and patient symptoms and information and is not intended to independently direct therapy.
See the instructions for use for more information.
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SOURCE Implicity