The PERICLOSE project addresses an unmet medical need: the closure of perimembranous ventricular septal defects (pmVSDs), the most common congenital heart defect in both children and young adults. Currently available treatments, whether surgical (open-heart procedures with associated morbidity) or percutaneous (using devices outside their official regulatory indication), have significant limitations, particularly in terms of postoperative complications.

This project aims to validate a novel device specifically designed to match the anatomical characteristics of pmVSDs, with a focus on safety, efficacy, and clinical feasibility, while reducing the risks associated with current approaches.

The project is based on a collaboration between INSERM UMR_1358, Hôpital Marie Lannelongue, the MALIC, and its strategic academic partners, 3DHeartModeling, and INRIA. The main steps include: (1) Design of a detailed digital model using computer-aided design software; (2) Preparation of documentation for patent filing; (3) Numerical simulations to assess device adaptability; (4) Prototype manufacturing using Nitinol microbraiding; (5) Standardized mechanical testing; (6) Preclinical evaluation using 3D heart models and simulators to assess feasibility and efficacy under controlled conditions.

PERICLOSE offers a minimally invasive solution for the closure of pmVSDs, thereby reducing procedural complications and improving patients’ quality of life. It involves the development of a patentable device incorporating advanced materials and an innovative design, positioning France as a leader in congenital interventional cardiology. The results will be published in high-impact journals and presented at international conferences, further enhancing scientific visibility.

Economically, this project could reduce hospital costs associated with traditional surgery, expand access to care worldwide, and strengthen the French medical device industry. Finally, it establishes a solid foundation for future funding and technology transfer to other clinical applications.