FDA Clears Simbionix TEVAR, EVAR and Carotid Intervention Simulators

 

April 2, 2013

April 2, 2013 — Simbionix USA Corp. has received U.S. Food and Drug Administration (FDA) clearance for its thoracic endovascular aneurysm repair (TEVAR) application for PROcedure Rehearsal Studio (PRS). This application joins the family of PRS cleared for marketing applications for carotid intervention and endovascular aneurysm repair (EVAR) 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 3-D anatomical model based on a specific patient's computed tomography (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 3-D model has been exported to the Simbionix 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 physicians.

According to 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."

For more information: www.simbionix.com

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