FDA clears EVAR application for Simbionix PROcedure Rehearsal Studio


On 23 February, Simbionix announced that it has received FDA clearance for the endovascular aneurysm repair (EVAR) application for the PROcedure Rehearsal Studio. This software transforms the patient’s CT scan into a 3D visualisation model. 

Simbionix has developed a revolutionary technology to use this 3D visualisation model within its endovascular simulator, the Angio Mentor, to allow surgeons to evaluate endovascular surgical treatment options before surgery. The PROcedure 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 Yael Friedman, director of Regulatory Affairs, 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,” Friedman said. “We are very proud that the FDA has cleared the EVAR application and continues to recognise the clinical component of the PROcedure Rehearsal Studio.” 

Last year Simbionix received clearance for the PROcedure Rehearsal Studio carotid intervention application.