FDA Cleared New Application for Simbionix PROcedure Rehearsal Studio
Cleveland, OH: Simbionix USA Corporation, the world’s leading provider of medical education and simulation training, is pleased to announce that Simbionix received FDA clearance for the EVAR (Endovascular Aneurysm Repair) application for the PROcedure Rehearsal Studio™ (PRS). Last year Simbionix received clearance for the PRS Carotid Intervention application.
The PROcedure Rehearsal Studio transforms the patient’s CT scan into a 3D visualization model. Simbionix has developed a revolutionary technology to use this 3D visualization model within its endovascular simulator, the ANGIO Mentor, to allow surgeons to evaluate endovascular surgical treatment options before surgery. PRS provides a 3D model of the patient’s vasculature and true-to-life vessel measurement tools.
After exporting the 3D model into the ANGIO Mentor simulator practice environment, the physician is able to train and practice aneurysm repair on the patient’s specific anatomy. For the first time, surgeons can practice endovascular abdominal aortic aneurysm repair, including precise deployment of the bifurcated and contralateral leg stent graft, deployment of iliac and aortic extensions and touch-up ballooning.
According to Dr. Yael Friedman, Director of Regulatory Affairs for Simbionix, the Simbionix track record in advanced medical education and training is unmatched, with more than 140 studies documenting the effectiveness and value of Simbionix medical simulators. “Based on this foundation, and on quality control, development, and production processes that were put in place over the past few years, we are pleased to be able to move beyond training and also provide the market with a clinical tool,” Dr. Friedman said. “We are very proud that the FDA has cleared the EVAR application and continues to recognize the clinical component of the PROcedure Rehearsal Studio.”