GEPROVAS (European Research Group on Prostheses Applied to Vascular Surgery) is a non-profit organization under local law created in 1993. It was born from the common will of Pr. Nabil Chakfé, vascular surgeon (Strasbourg), and Pr. Bernard Durand (Mechanics of flexible materials, ENSISA - Mulhouse) to understand and characterize the complications which occurr on vascular prostheses, in particular the phenomena of tearing and rupture observed after implantation in patients.
It promotes public health by targeting the implementation of an adapted and individualized medicine.
The constitution of a non-profit structure is based on the will to promote, in addition to humanistic and ethical values linked to the continuous improvement of the safety of care:
It benefits from the support of the Grand Est Region, the Eurometropole, the European Collectivity of Alsace, the University and the University Hospitals of Strasbourg. Strong connections are established with Nextmed, Biovalley France. It collaborates with the legal department of the University of Lorraine and many other local, national and international research and training structures. Numerous industrial partners from the world of health are associated with its activities.
Since 2019, it is located in partially renovated premises within the medical campus of the University of Strasbourg. Its expertise is internationally recognized and numerous collaborations with European and North American teams contribute to its reputation. The importance of the scientific publications reflects this.
Implantable medical devices (IMD) have revolutionized surgery. They have mainly been developed by the industry. Institutional research is developing various concepts and structural advances that are not often enough transferred to the industrial domain.
They are subject to regulatory frameworks aimed at protecting the patient. This regulation has limitations, both before implantation in the absence of predictive tests of their long-term behavior, and after implantation in the absence of a comprehensive material vigilance program and feedback on failures.
The very basis of the concept is a multi-scale approach to IMD qualified by the implant cycle integrating four levels of interactive expertise:
It must be possible to test and evaluate IMDs independently and autonomously from the industry. This evaluation is a source of development both in terms of the possibility of creating new concepts that could be used for the benefit of the patient, but also to work on the knowledge of long-term behavior.
Teaching by observation is no longer enough. The sophistication of IMDs requires specific learning methods to master the techniques of placement and associated imaging. Education and training allow professionals to know the characteristics of the IMDs used, to obtain certification after an initial training phase and re-certifications linked to the turnover of new technologies.
This approach includes team learning and uses artificial intelligence technologies. It contributes to the research and development activity based on ideas from healthcare professionals aiming to continuously improve the quality and safety of their practices.
This registry activity is fundamental to the monitoring of medical devices. It is both a means of early detection of possible unexpected complications and of long-term evaluation of complications. These follow-up studies are regulatory and must be integrated into the design and marketing of an implant.
Explant analysis has been undervalued. A parallel with aviation allows us to identify the work to be done. When a major complication occurs, all parts are systematically analyzed by an Accident Investigation Bureau (AIB) to avoid a new incident. This strategy has been developed by GEPROVAS for many years and must take a fundamental place as the AIB for IMDs.
Primarily structured for vascular surgery with prostheses and stents, and after years of analysis, structuring, and validation of the implant cycle in the field of vascular surgery and the acquisition of unique expertise, the major concept can be replicated into other fields using IMDs in order to protect the patient by ensuring the safety and effectiveness of these devices.