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Third FDA Clearance for Revolutionary Simbionix Product
Date:3/29/2013

CLEVELAND, March 29, 2013 /PRNewswire/ --



Simbionix USA Corporation, the world's leading provider of medical education and simulation training, has received FDA clearance for its TEVAR (Thoracic Endovascular Aneurysm Repair) application for PROcedure Rehearsal Studio™ (PRS). This application joins the family of PRS cleared for marketing applications for Carotid Intervention and EVAR (Endovascular Aneurysm Repair) procedures.

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TEVAR is an emerging treatment modality, which has been rapidly embraced by clinicians treating thoracic aortic disease. It is a far less invasive approach than open surgery. Additionally, the availability and relative ease of application with TEVAR has changed and extended management options in thoracic aortic disease, including in patients deemed unsuitable for open surgery. The skills necessary to perform TEVAR require dedicated formal training, as this procedure requires considerable perceptual, cognitive and psychomotor demands on the surgeons.

The PROcedure Rehearsal Studio utilizes revolutionary technology, developed by Simbionix, allowing physicians to rehearse a complete endovascular procedure on a virtual 3D anatomical model based on a specific patient's CT data. The virtual model may then be used for the purpose of simulating, analyzing and evaluating preoperative surgical treatment options prior to performing the actual procedure, which may increase physician's confidence in the upcoming procedure. Once the 3D model has been exported to the Simbionix
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SOURCE Simbionix USA Corporation
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