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:5/15/2017)... , May 15, 2017 Enterin Inc., a ... and developing novel compounds to treat Parkinson,s disease (PD), ... study is a Phase 1/2a randomized, controlled, multicenter study involving ... It will enroll 50 patients over a 9-to-12-month period. The ... in 10 patients with PD. Participating sites include ...
(Date:5/11/2017)... , May 11, 2017  Thornhill Research ... has been awarded an $8,049,024 USD five-year, firm-fixed-priced, ... through the Canadian Commercial Corporation (CCC) ( ... Anesthesia Systems to administer general anesthesia to patients ... "The US Marine Corps have been ...
(Date:5/10/2017)... , May 10, 2017 Global Health Intelligence ... Latin America , published its 2017 ranking of ... is based on extensive data analysis from GHI,s hospitals ... hospitals database for the region. The GHI database covers 86% ... offering more than 130 data points for each institution in ...
Breaking Medicine Technology:
(Date:5/24/2017)... ... May 24, 2017 , ... Last month, representatives ... hospital employees, and town officials to celebrate the grand opening of the 87,000 ... Rendina as part of its ongoing relationship with RWJBarnabas Health, New Jersey’s largest ...
(Date:5/24/2017)... ... May 24, 2017 , ... Dr. Alan I. Benvenisty, MD is dual board ... He is known for his distinguished expertise and experience in the diagnosis and treatment ... training in treating renovascular disease and aortic aneurysm . He is known for ...
(Date:5/24/2017)... ... May 24, 2017 , ... ... and interpretation, has received U.S. Food and Drug Administration (FDA) 510(k) clearance ... scalable and secure cloud platform for medical image management. At the core is ...
(Date:5/24/2017)... ... 2017 , ... Dr. Manju R. Kejriwal, a leading Ohio dentist, is now ... a referral. Dr. Kejriwal understands the emotional and financial toll traditional orthodontics can take ... Patients no longer need to feel the esthetic effects of wires and brackets when ...
(Date:5/24/2017)... ... May 24, 2017 , ... STATEMENT OPPOSING ... vehemently opposed to Donald Trump’s budget, “A New Foundation for American Greatness—President's Budget ... demonizes the poor, marginalizes underserved populations, undermines productivity, and destroys the social safety ...
Breaking Medicine News(10 mins):