Third FDA Clearance for Revolutionary Simbionix Product
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
[http://simbionix.com/clinical-rehearsal/library-of-modules/tevar ] for PROcedure Rehearsal
Studio(TM) (PRS) [http://simbionix.com/clinical-rehearsal ]. This application joins the
family of PRS cleared for marketing applications for Carotid Intervention
[http://simbionix.com/clinical-rehearsal/library-of-modules/carotid ] and EVAR
(Endovascular Aneurysm Repair) procedures
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
ANGIO Mentor(TM) [http://simbionix.com/simulators/angio-mentor ] simulation environment,
the physician can practice numerous times to evaluate different techniques, while using
true-to-life tools and endografts.
The Society of Vascular Surgery suggests that surgeons perform a minimum of 100
diagnostic, 50 interventional and 10 TEVAR cases to become certified. With this new
innovative application, physicians can actually receive hands-on training in TEVAR
procedures, including precise deployment of single and multiple stent grafts, as well as
touch-up ballooning, before operating on a live patient. The PRS simplifies procedure
planning, and provides a comprehensive solution for training and simulation of patient
specific procedures aimed to enhance the professional level of both experienced and novice
According to Dr. Yael Friedman, Director of Regulatory Affairs for Simbionix, the
Simbionix track record in providing healthcare professionals with innovative simulation
tools is the foundation of yet another successful product. “Thoracic Endovascular Aneurysm
Repair is one of the most advanced medical procedures that endovascular surgeons perform.
Simbionix is extremely pleased to have received the FDA clearance and proud of our new
PROcedure Rehearsal Studio clinical TEVAR application which will help clinicians in
analyzing and evaluating preoperative surgical treatment options.”
Simbionix USA Corporation [http://www.simbionix.com ] 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 Facebook
[https://www.facebook.com/pages/Simbionix/328515966636 ], Twitter
[https://twitter.com/SimbionixUSA ] and LinkedIn [http://www.linkedin.com/company/35459 ].
Contact: Rebecca Levy, Manager of Marketing Communications, at
SOURCE Simbionix USA Corporation