[Innovative medical devices in France: A descriptive study based on public healthcare databases]

In healthcare institutions, innovative medical devices (MDs) represent a growing challenge in terms of care quality and budget control. However, their diffusion in hospital settings remains poorly documented. This study aims to characterize MDs considered innovative by the French National Authority for Health (HAS) and to analyze their level of adoption in French healthcare institutions.

A database was built using public sources (HAS, CNAM, OMEDIT, ATIH) covering the period from 2019 to 2024. Innovative MDs were selected based on their clinical added value (ASA/ASR) level (I to IV) and their inclusion in Titles III and V of the list of reimbursable products and services (LPPR). The distribution of usage between public and private institutions, as well as the typology of MDs, was analyzed.

Our study includes 835 records (2262 LPP codes). The majority of reimbursement amounts from the add-on payment list (LES) are attributed to brand name MDs with an ASA V rating (77-83% of amounts from 2019 to 2024). MDs considered innovative (ASA I to IV) account for 9.7 to 11.7% of LES reimbursement amounts (197-261 million euros over 2019-2024), and are predominantly used in public institutions. The annual distribution of ASA/ASR levels remains very stable throughout the study period. The main medical fields involved are cardiovascular, orthopedics, electrophysiology, and neuromodulation.

This initial mapping shows a stronger adoption of innovative MDs in the public sector and highlights the need for better interoperability between databases to enhance monitoring of hospital innovation.