In-Silico Testing and Validation of Cardiovascular IMplantable devices (SIMCor)

Unknown Systolic configuration in front of the TAVI peak shows the opened native bicuspid leaflet (left) and the deformed configuration of the TAVI device (right). Image from Pasta et al. (2020).

The complexity and speed of technological innovation with ever shorter product cycles leads to an enormous demand for standardized best practices in order to apply in-silico validation methods in a statistically robust, repeatable, and efficient manner. SIMCor will address this challenge by providing manufacturers of cardiovascular implantable devices with an open, reusable, cloud-based platform for in-silico testing to accelerate development and regulatory approval of their products. The platform will support device validation along the whole R&D pipeline: from initial modeling and in-vitro experiments to animal studies and device implantation and effect simulation on human cohorts.

In particular, SIMCor innovative virtual cohort technology will allow to generate and expose new or existing devices to a range of clinically realistic and diversified anatomies and (patho)physiological conditions, also including extensive pediatric populations, meeting the critical need of testing devices in young patients. A standardized multi-level validation process and sensitivity analysis will guarantee statistical credibility for in-silico tests and the platform as a whole, proving solid experimental ground for regulatory authorities, thus accelerating approval and time to market for new products, reducing the burden of human and animal studies and boosting innovation at large. High-priority safety, efficacy and usability endpoints will be investigated, focusing on device implantation and effect simulations in two representative areas: transcatheter aortic valve implantation (TAVI) and pulmonary artery pressure sensors (PAPS). Based on the results of the proof-of-validation and regulatory approval for these use cases, SIMCor will define standard operating procedures and a generalized technical framework for in-silico testing, validation and regulatory approval of cardiovascular devices to be made available to researchers, medical device manufacturers and regulatory agencies.

Briefly, in this project, we (TU Graz, Institute of Biomechanics) are responsible for the development of constitutive models of the ascending aorta and the pulmonary artery for the deployment of virtual devices in the cardiovascular system and the simulation of device-specific effects in regard to safety, efficacy and usability endpoints. In addition, we perform experimental tests on animal and human tissues, which include mechanical tests and structural investigations, to validate the developed constitutive models.

Funding: European Union