72 - “Capturing Anatomical Diversity: Virtual Populations for In Silico Trials of Cardiac Devices”
Abstract
Bench and animal testing, and early clinical studies provide critical baseline evidence of device safety and efficacy prior to large-scale clinical trials. But none comes close to capturing the range of real-world operating conditions a device can be expected to experience. Even at pivotal trial stage, recruitment and retention challenges, and careful design of inclusion/exclusion criteria make it difficult to generate evidence for rare and under-represented patient sub-groups. Consequently, under-testing of devices, even those successfully navigating regulatory pathways, is a chronic and growing problem. In silico methods are built to close this gap.
In this webinar, adsilico introduces its Virtual Chimera technology for generating large, statistically representative cohorts of synthetic virtual patients, and shows how validated simulation can complement early clinical data with population-scale mechanistic evidence. We will cover the Virtual Chimera concept and approach, and its potential benefits in promoting inclusivity in device testing. We will further describe how Virtual Chimeras underpinned recent work with an industry partner focused on in silico biomechanical assessment of a novel transcatheter mitral annuloplasty device, highlighting the types of insights that can be derived from such analyses.
