New Medical Devices in Cardiology

The Grenoble scientific ecosystem, rich in clinical, technological, and industrial expertise, provides a fertile environment for ambitious projects. The INSERM unit, in collaboration with Grenoble Alpes University Hospital (CHUGA), Université Grenoble Alpes (UGA), and several partners (TIMC, LTSI, CEA, CLINATEC, IAB, IGE, GIPSA-Lab, etc.), is conducting structured clinical studies and collaborative research projects to evaluate new medical devices (MDs) using imaging:

• SuperSaturated Oxygen Therapy (SSO₂): In partnership with the company ZOLL, the IC HOT MICRO clinical trial (NCT05790876) is investigating the effects of this innovative therapy on coronary microcirculation following a STEMI event, using automated angiographic analysis.

• HT Supreme Stents: In collaboration with the startup AlchiMedics (CEA) and SINOMED, we are coordinating the multicenter DIOHR study on a novel stent featuring electrochemically grafted polymers.

• Red-Light Photobiomodulation (PBM) Therapy: Developed with the CEA, CLINATEC, and Professor Mitrofanis, this therapeutic vest will be evaluated in post-infarction patients using echocardiography and MRI.

The unit is also involved in the development of imaging software solutions considered medical devices, often enhanced by AI technologies:

• Guided Injection of CD34⁺ Cells: Development of an MRI-fluoroscopy fusion software to guide cell therapy procedures following myocardial infarction with greater precision.
   
• AIDE2MB: A biopsy guidance tool combining MRI and FDG-PET imaging, using personalized 3D modeling to improve diagnostic yield of myocardial biopsies.
   
• Automated Interpretation of Stress Echocardiography: A deep learning algorithm is currently being developed (with support from interregional PHRC funding), using a multicenter image database from University Hospitals in Grenoble, Lyon, Saint-Étienne, and Clermont-Ferrand.
   
• Personalized Prognosis Prediction Post-Infarction: The CADHO study (NCT05316025) aims to combine clinical, biological, environmental, and imaging data using AI to predict cardiovascular risk. This initiative involves numerous partners (TIMC, ATMO, Biogroup, CHU’s health data warehouse, etc.) and is currently seeking funding.
   

All these projects are coordinated through our CoroTECH CoreLab, which centralizes imaging data, supports AI algorithm training, and enables the development of next-generation diagnostic and prognostic solutions. CoroTECH plays a key role in advancing the development, evaluation, and deployment of breakthrough technologies in cardiology.