Last updated on April 23, 2014 at 13:51 EDT

FDA Cleared New Application for Simbionix PROcedure Rehearsal Studio

February 23, 2012

CLEVELAND, February 23, 2012 /PRNewswire/ –

Simbionix USA Corporation, the world’s leading provider of medical education and
simulation training, is pleased to announce that Simbionix received FDA clearance for the
EVAR [http://simbionix.com/clinical-rehearsal/library-of-modules/evar ] (Endovascular
Aneurysm Repair) application for the PROcedure Rehearsal Studio(TM)
[http://simbionix.com/clinical-rehearsal ] (PRS). Last year Simbionix received clearance
for the PRS Carotid Intervention application.


The PROcedure Rehearsal Studio transforms the patient’s CT scan into a 3D
visualization model. Simbionix has developed a revolutionary technology to use this 3D
visualization model within its endovascular simulator, the ANGIO Mentor, to allow surgeons
to evaluate endovascular surgical treatment options before surgery. PRS 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 Dr. Yael Friedman, Director of Regulatory Affairs for 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,” Dr. Friedman said. “We are
very proud that the FDA has cleared the EVAR application and continues to recognize the
clinical component of the PROcedure Rehearsal Studio.”

About Simbionix USA Corporation [http://simbionix.com/company ]

Simbionix is the world’s leading provider of simulation, training and education
products for medical professionals and the healthcare industry. The company is committed
to delivering high quality products, advancing clinical performance and optimizing
procedural outcomes.

        Visit: http://www.simbionix.com
        Contact: Rebecca Levy, Manager of Marketing Communications, at

        +1-216-229-2040 Ext 128



SOURCE Simbionix USA Corporation

Source: PR Newswire