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
(-103EUR) 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
1. N. Varma et al., "Impact of a universal monitoring system ('third party')
on outcomes of ICD patients: A nationwide study," Heart Rhythm, 2024.
2. IM009: 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.
3. IM007: 2021. ILR ECG ANALYZER created by Implicity is intended to be used
by qualified healthcare professionals for the assessment of arrhythmias
in Insertable Cardiac Monitor (ICM) ECG data. ILR ECG ANALYZER supports
downloading and analyzing data recorded in compatible formats from ICMs.
This version of the ILR ECG ANALYZER only supports ECG data from
Medtronic ICMs. ILR ECG ANALYZER is intended to be electronically
interfaced with other computer systems (remote monitoring platforms) that
supply the ECG data to ILR ECG ANALYZER and receive the output of ILR ECG
ANALYZER (analysis) for viewing by healthcare professionals. ILR ECG
ANALYZER provides ECG signal processing and analysis, to detect asystole,
bradycardia, atrial tachycardia or atrial fibrillation, ventricular
tachycardia, normal rhythm and artifacts. ILR ECG ANALYZER is not for use
in life supporting or sustaining systems or ECG monitor and Alarm
devices. ILR ECG ANALYZER interpretation results are not intended to be
the sole means of diagnosis. It is offered to physicians and clinicians
on an advisory basis only in conjunction with the physician's knowledge
of ECG patterns, patient background, clinical history, symptoms, and
other diagnostic information. ILR ECG ANALYZER is interfaced with the
compatible remote monitoring platform from which it receives compatible
ICM data file input (Medtronic LNQ11 Medtronic REVEAL XT 9529 Medtronic
REVEAL DX 9528) and to which it transmits the output. Read carefully all
instructions before use. Results: sensitivity: 98.64 % (509/516), false
positive rate: 24.03 % (68/283). FDA cleared Class II medical device and
CE marked Class I medical device (under medical device directive
93/42).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.
Media Contact:
Sam Choinski
eMedia Junction
860-301-5058
samantha@emediajunction.com
View original content to download multimedia:https://www.prnewswire.com/news-releases/implicitys-evidence-rm-study-demonstrates-marked-improvement-in-icd-patient-outcomes-302436176.html
SOURCE Implicity
