The Food & Drug Administration granted 510(k) clearance to the PROcedure Rehearsal Studio software made by Cleveland’s Simbionix USA Corp., opening the door to advanced simulation technologies for practicing clinicians.
The software is used to transfer imaging data, such as from a CT scanner, to an output file. It also is used as pre-operative software to simulate and evaluate surgical treatment options. Simbionix makes medical training simulators.
“We are extremely pleased to have received the FDA clearance, allowing us to offer new and advanced technologies for use in daily clinical practice as well as in training,” Simbionix CEO Gary Zamler said in prepared remarks. “The PROcedure Rehearsal Studio software was designed to help clinicians deliver better patient care and to enhance patient safety through timely and realistic practice.”
Unique to the Simbionix simulation systems, the 3D segmentation model can be exported to the Simbionix ANGIO Mentor Simulator, creating a library of modules for training and post-operative debriefing.
“We have been using the PROcedure Rehearsal Studio in our research and educational programs, and it has lived up to our fullest expectations,” said Dr. Karl Illig, professor of surgery and neurosurgery, and chief of the Division of Vascular Surgery at the 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,” Illig said. “In my opinion, this is clearly the next step for medical simulation, where simulators will be able to be used to plan a procedure.”