Overcoming roadblocks in clinical innovation via high fidelity simulation: use of a phantom simulator to achieve FDA and IRB approval of a clinical trial of fetal embolization of vein of Galen malformations

Conclusions
A phantom simulator for fetal intervention of VOGM produces lifelike results during trial interventions, removing obstacles to feasibility and safety evaluations, typically precluded by non-availability of appropriate animal models. The study provides a proof of concept for potentially wider applications of medical simulation to enable novel procedural advancements in neurointerventions.

Source: Journal of NeuroInterventional Surgery - November 16, 2023 Category: Neurosurgery Authors: Orbach, D. B., Wilkins-Haug, L. E., Benson, C. B., Rangwala, S. D., Pak, C., Saffarzadeh, M., Weinstock, P. Tags: New devices New devices and techniques Source Type: research