FDA Clears Pre-Operative Simulation System


September 30, 2010

September 30, 2010 – The U.S. Food and Drug Administration (FDA) has cleared a software interface and image segmentation system that can help simulate and evaluate surgical treatment options.

The PROcedure Rehearsal Studio, by Simbionix, transfers imaging data from a medical scanner to an output file and can also act as a pre-operative tool for simulating and evaluating treatment options. Additionally, a 3-D segmentation model can be exported to the Angio Mentor Simulator practice environment.

"We have been using the PROcedure Rehearsal Studio in our research and educational programs, and it has lived up to our fullest expectations,” said Karl A. Illig, M.D., professor of surgery and neurosurgery and chief, division of vascular surgery, University of Rochester Medical Center. “We began to practice using our carotid stents on the simulator before performing them in the operating room in 2008, and have been very impressed by its ability to improve our subsequent procedures. In my opinion, this is clearly the next step for medical simulation, where simulators will be able to be used to plan a procedure."

For more information: www.simbionix.com