Villepinte (France) - May 19, 2020 - 06:00 pm CET - Guerbet, a global leader in medical imaging, announces the registration of Vectorio®, kit for imaging of hepatocellular carcinoma (HCC), in Canada.
Vectorio® is a set of Lipiodol® resistant medical devices,(1) including patented syringes, stopcock and sampling devices.
Vectorio® is dedicated to Lipiodol® Ultra Fluid Injection for imaging of liver tumors in adults with known hepatocellular carcinoma during interventional oncology procedures.
HCC is the most common primary liver cancer and is the fourth biggest cause of death due to cancer worldwide (2).
This medical device:
· Is 24 hours Lipiodol® Ultra Fluid resistant (1)
· Contains Patented 3-way stopcock with 4 connections offering possibility of "On-table Refill & optimized injection control" (interventional radiologists have the possibility of refill without disconnection from the micro-catheter)
· Includes all devices in one set
· Is user-friendly and allows ergonomic and quick device set-up.
Designed and manufactured in France, Vectorio® started its commercial launch in September 2017 in European countries. Today, Vectorio® for imaging of HCC is registered in Canada & Germany. Vectorio® is also registered in 25 countries where cTACE procedures are approved for Lipiodol Ultra Fluid (3,4).
1. Test report (E17-41) - Verification report of the device's functionality after 24h exposure to Lipiodol
2. WHO - Globocan 2018 (IARC) Global Cancer Observatory.
3. Vectorio® is registered for HCC imaging in Canada and Germany. Vectorio® is also registered for cTACE in EMEA (Austria, Belgium, Czech Republic, Denmark, France, Hungary, Ireland, Luxembourg, Portugal, Switzerland, The Netherlands, Turkey), Americas (Argentina, Brazil, Ecuador, Mexico, Peru) and Asia-Pacific (Australia, Hong Kong, India, New Zealand, South Korea, Taiwan, Thailand, Vietnam).
4. Countries in which cTACE indication is registered for Lipiodol® Ultra Fluid: EMEA (Austria, Belgium, Czech Republic, Denmark, France, Hungary, Iran, Ireland, Luxembourg, Portugal, Switzerland, The Netherlands, Tunisia, Turkey), Americas (Argentina, Colombia, Brazil, Chile, Mexico, Peru, Uruguay), Asia-Pacific (Australia, Brunei Darussalam, Cambodia, Hong Kong, India, Mongolia, New Zealand, Philippines, South Korea, Sri Lanka, Taiwan, Thailand, Vietnam). Countries in which HCC imaging indication is registered for Lipiodol® Ultra Fluid: Canada, Germany, United States of America.
Vectorio® is a sterile medical device set of class Is (CE 0459) intended to be used by healthcare professionals only. It has been validated for resistance to Lipiodol® up to 24h. For complete information please refer to country's local Package Information Leaflet & Vectorio® Instruction for Use (IFU). Vectorio® is manufactured by Medex, a Guerbet group company.
Lipiodol® Ultra-Fluid (ethyl esters of iodized fatty acids of poppyseed oil) was initially developed for diagnostic radiology in indications including liver lesion diagnosis, lymphography and hysterosalpingography, and then used in interventional radiology for visualization and localization of liver lesions in adults with known or suspected hepatocellular carcinoma (HCC). The approved indications for Lipiodol® Ultra-Fluid may vary according to countries. Please refer to local SmPC for further information.
Guerbet is a leader in medical imaging worldwide, offering a wide range of pharmaceutical products, medical devices, digital and AI solutions for diagnostic and interventional imaging, to improve the diagnosis and treatment of patients. A pioneer since more than 90 years in the field of contrast media with over 2,800 people globally, Guerbet is continuously innovating with 9% of revenue dedicated to Research & Development and four centers in France, Israel and the United States. Guerbet (GBT) is listed on Euronext Paris (segment B - mid caps) and generated €817 million in revenue in 2019. For more information about Guerbet, please visit www.guerbet.com.