Navigation Links
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.

     (Logo: http://photos.prnewswire.com/prnh/20120502/529202-a)

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™ 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 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 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   FacebookTwitter and LinkedIn.

Contact: Rebecca Levy , Manager of Marketing Communications, at rebecca@simbionix.com, +1-216-2292040



'/>"/>
SOURCE Simbionix USA Corporation
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Perrigo Company Will Release Third Quarter Fiscal 2012 Results On May 8, 2012
2. PAREXEL Reports Third Quarter Fiscal Year 2012 Financial Results
3. Pro-Dex, Inc. Announces Fiscal 2012 Third Quarter Financial Results Conference Call and Webcast
4. Techne Corporation Releases Unaudited Third Quarter and Nine Month Fiscal Year 2012 Results
5. Cardica Announces Fiscal 2012 Third Quarter Financial Results
6. Hill-Rom Announces Third Quarter 2012 Dividend
7. Cardinal Health Reports Third-Quarter Results
8. TPI to Host Third Quarter of Fiscal Year 2012 Earnings Conference Call on Tuesday, May 15, 2012 at 9:00 a.m. ET
9. Pro-Dex, Inc. Announces Fiscal Third Quarter and Nine Month Results
10. ThermoGenesis Corp. To Announce Third Quarter Fiscal 2012 Results On May 10, 2012
11. Perrigo Reports Record Third Quarter Revenue And Earnings And Raises Full Year EPS Guidance
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/22/2017)... 22, 2017  As the latest Obamacare repeal effort ... Cassidy (R-LA) and Lindsey Graham (R-SC) ... medical device industry is in an odd place.  The ... 2.3% excise tax on medical device sales passed along ... covered patients, increased visits and hospital customers with the ...
(Date:9/18/2017)... Pa. and KALAMAZOO, Mich. , Sept. 18, ... , and OptiMed Specialty Pharmacy of ... to offer a strategic hub service that expedites and ... sought-after personal spirometer, Spiro PD 2.0, and wellness management ... spirometer is a medical device used to measure lung ...
(Date:9/12/2017)... , Sept. 12, 2017  Consumer reviews on the independent review ... as the number one company for hearing aids, ranking it higher ... other brands. ... Named #1 by Consumers For Hearing Aids ... Embrace Hearing is an online store that provides high performance, state-of-the-art, ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... 2017 , ... Many families have long-term insurance that covers care for a ... waiver for care if the client has a cognitive impairment diagnosis. , “What ... is often waived, so the benefits from their insurance start immediately,” said Mechell Vieira, ...
(Date:10/13/2017)... ... ... Ellevate Network, the leading network for professional women, brought together some of ... their inaugural Summit in New York City in June. The event was livestreamed with ... 3 million. To watch the Mobilize Women video, click here . , ...
(Date:10/13/2017)... ... October 13, 2017 , ... Yisrayl Hawkins, Pastor and Overseer ... one of the most popular and least understood books in the Holy Scriptures, Revelation. ... descriptions that have baffled scholars for centuries. Many have tossed it off as mere ...
(Date:10/13/2017)... ... 13, 2017 , ... Coveros, a leader in agile coaching ... contract by the Center for Medicare and Medicaid Services (CMS). The Enterprise Agile ... of Agile methodologies in a consistent and high value manner across CMS programs. ...
(Date:10/13/2017)... ... October 13, 2017 , ... “America On The Brink”: the Christian history ... The Brink” is the creation of published author, William Nowers. Captain Nowers and ... WWII veteran, he spent thirty years in the Navy. Following his career as ...
Breaking Medicine News(10 mins):