Simbionix Receives FDA Clearance

Simbionix Ltd., a subsidiary of Simbionix USA Corporation, the world’s leading provider of medical education and simulation technology, is proud to announce the receipt of FDA clearance for the PROcedure Rehearsal StudioTM™ Software.

The PROcedure Rehearsal Studio software is intended for use as a software interface and image segmentation system for the transfer of imaging data from a medical scanner such as a CT scanner to an output file. It is also intended as pre-operative software for simulating and evaluating surgical treatment options. Unique to the Simbionix simulation systems, the 3D segmentation model can be exported to the Simbionix ANGIO MentorTM Simulator practice environment. The results are an advanced method of creating an ever expanding library of modules for training and post-operative debriefing.

Dr Karl A. Illig, Professor of Surgery and Neurosurgery and Chief, Division of Vascular Surgery, University of Rochester Medical Center comments: “We have been using the PROcedure Rehearsal Studio in our research and educational programs, and it has lived up to our fullest expectations. 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.”

“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”, says Gary Zamler, Simbionix CEO. “The PROcedure Rehearsal Studio software was designed to help clinicians deliver better patient care and to enhance patient safety through timely and realistic practice. Once again, we are able to prove that Simbionix is constantly innovating and stretching technological boundaries.”