FDA Clears Simbionix Technology for TEVAR Simulation

March 29, 2013—Simbionix USA Corporation (Cleveland, OH), a provider of medical education and simulation training, has received US Food and Drug Administration clearance for a thoracic endovascular aneurysm repair (TEVAR) application for its Procedure Rehearsal Studio (PRS). Simbionix PRS technology has previously been cleared for carotid intervention and endovascular aneurysm repair procedure applications.

According to Simbionix, the PRS uses the company's technology that allows interventionists to rehearse a complete endovascular procedure on a virtual three-dimensional anatomical model based on a specific patient's CT data. The virtual model may then be used for the purpose of simulating, analyzing, and evaluating preoperative surgical treatment options before performing the actual procedure, which may increase physician confidence in the upcoming procedure. The 3D model can be exported to the Simbionix Angio Mentor simulation environment, and the interventionist can practice numerous times to evaluate different techniques while using true-to-life tools and endografts.

The company noted that TEVAR demands considerable perceptual, cognitive, and psychomotor skills of interventionists and that the Society of Vascular Surgery suggests that interventionists should perform a minimum of 100 diagnostic, 50 interventional, and 10 TEVAR cases to be skilled in these interventions. This new application allows physicians to receive hands-on training in TEVAR procedures, including precise deployment of single and multiple stent grafts and touch-up ballooning, before operating on a live patient. The PRS simplifies procedure planning and provides a comprehensive solution for training and simulation of patient-specific procedures aimed to enhance the professional level of both experienced and novice physicians, stated Simbionix.