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The network provides a comprehensive offering to structure, conduct and add value to preclinical studies, from protocol design to interpretation of results. 
Our teams mobilize complementary expertise in numerical modeling, biological experimentation and functional analysis, to meet device validation requirements prior to use in humans.

Modeling & digital simulation

• Mathematical and digital modeling (high-performance computing algorithms and supercomputers)
• Design of digital twins of the heart to simulate device operation under realistic conditions.
• Advanced digital simulation to test medical or biological hypotheses in-silico, produce synthetic ECGs (or other biomarkers) and evaluate device performance.
• Study of biological mechanisms of ablation and optimization of defibrillation methods
• Inverse electrocardiographic imaging to visualize device effects on cardiac electrical activity

Signal analysis & algorithm development

• Instrumentation and processing of electrophysiological signals (ECG, EGM, mapping).
• Development of customized analysis tools to visualize and quantify device effects.
• Interface with numerical simulations and experimental results for an integrated approach

Invitro, ex vivo & in vivo experimentation

• In vitro : Cytocompatibility and cytotoxicity testing, cell-material interaction studies (cell-material interface, hemocompatibility, tissue engineering), advanced cellular techniques (patch-clamp, confocal microscopy, microspectrofluorimetry), Bioenergetic studies
• Ex vivo: Functional tests on isolated-perfused heart models, under physiological conditions, optical mapping of electrical activation, tests on human tissue, tissue analyses (histology, immunohistochemistry, histo-morphometry), scanning electron microscopy (SEM)
• In vivo: Biocompatibility and biofunctionality assessment, proof-of-concept studies in animal models, clinical and biological follow-up of experiments, preclinical imaging (research MRI, conventional and photon-counting scanner, intraoperative 3D imaging, augmented reality)

Technical, functional and usage assessment

• Preclinical technical assessment: robustness, efficacy
• Advanced functional evaluation: pathophysiology studies, proof of concept
• Tests on mannequins, human cadavers, simulation models (in silico, in virtuo)
• Ergonomic and usability evaluation (fitness-for-use engineering process)

The network relies on reference preclinical platforms with high-performance facilities and equipment, including:

• Animal electrophysiology laboratory, reproducing the conditions of clinical procedure rooms.
• Advanced medical imaging technologies: Research MRI, photon-counting scanner, intraoperative 3D imaging, augmented reality...
• Modeling and experimental platforms dedicated to interventional electrophysiology.

Bioengineering facilities and medico-technical platforms, such as:

• TherA-Image, dedicated to interventional imaging and image-guided therapies.
• Archimed, a platform for the management and processing of clinical and preclinical imaging data
• LabTau, a laboratory equipped for the development and evaluation of biomedical devices in the ultrasound and mechanical fields

To meet the varied needs of our partners, we offer tailor-made, modular support depending on the maturity of the project:

• Regulatory Affairs Consulting (MDR 2017/745): European regulations for marketing, classification, risk analysis, safety and performance, applicable standards...
• Study design & project engineering: partnerships and calls for tender, protocols, regulatory and financial aspects, links with sponsors (DRCI, Inserm, industry) technical assessments
• Scientific consultancy and expertise: co-design of preclinical protocols
• Technical implementation & logistics coordination
• Valorization of results and support for clinical approaches: drafting of study reports, valorization

👉 We are able to co-construct preclinical stages with companies of all sizes, from start-ups to major groups.

REFeR-RYTHMO supports all types of medical devices related to interventional rhythmology and cardiovascular pathologies, including innovative technologies, digital devices or software solutions in the early stages of development. Our specialties include:

Simple and complex ablations

• Atrial fibrillation with international expertise in cryoablation, ventricular tachycardias, ventricular extrasystoles, atrial flutter, junctional tachycardia, Wolf-Parkinson-White syndrome, supraventricular tachycardias, Kent syndrome, cardioneuroablation
• Percutaneous closure of the left atrium by prosthesis

Implantable devices

• Pacemakers (with or without leads), defibrillators (endocavitary, subcutaneous and extravascular), pacemakers (leadless included), implantable cardiac monitors, automatic implantable defibrillators

Digital devices, software and Artificial Intelligence

• Remote programming, remote monitoring, digital twins, connected watches, signal processing...

Enhanced intervention technologies

• Electroporation, Marshall ablation technique, cardiac CT-guided ablation...

MRI compatibility and optimization

Other related fields

• Hereditary rhythmic diseases, risk scoring, lead extraction....

While these specialties constitute our core expertise, the network remains resolutely open to any other innovative approach, whether emerging devices or complementary approaches aimed at improving interventional rhythmology management.

REFeR-RYTHMO supports all types of medical devices related to interventional rhythmology and cardiovascular pathologies, including innovative technologies, digital devices or software solutions in the early stages of development. In particular, our specialties cover:

Simple and complex ablations

• Atrial fibrillation with international expertise in cryoablation, ventricular tachycardias, ventricular extrasystoles, atrial flutter, junctional tachycardia, Wolf-Parkinson-White syndrome, supraventricular tachycardias, Kent syndrome, cardioneuroablation
• Percutaneous prosthetic left atrial closure

Implantable devices

• Pacemakers (with or without leads), defibrillators (endocavitary, subcutaneous and extravascular), pacemakers (including leadless), implantable cardiac monitors, automatic implantable defibrillators

Digital devices, software and Artificial Intelligence

• Remote programming, remote monitoring, digital twins, connected watches, signal processing...

Enhanced intervention technologies

• Electroporation, Marshall ablation technique, cardiac CT-guided ablation...

MRI compatibility and optimization

Other related fields

• Hereditary rhythmic diseases, risk scoring, lead extraction....

While these specialties constitute our core expertise, the network remains resolutely open to any other innovative approach, whether emerging devices or complementary approaches aimed at improving interventional rhythmology management.