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Guerbet Announces CE Mark for Vectorio®, An Innovative Medical Device for cTACE Procedures

14-09-2017

Vectorio
®
will be presented at the upcoming radiology congresses






Villepinte (France), September 14, 2017 (6:00 PM CEST) -

Guerbet (FR0000032526 GBT), the global specialist in contrast products and solutions for medical imaging, announced today that it has obtained the CE mark for its innovative conventional Trans-Arterial Chemo-Embolization (cTACE) mixing and injection system, Vectorio
®
.

Designed in collaboration with interventional radiologists worldwide, Vectorio
®
is a unique set of Lipiodol
®
resistant medical devices including syringes, patented stopcock and sampling devices. Vectorio
®
is dedicated for mixing and delivering Lipiodol
®
Ultra Fluid & anticancer drugs during cTACE procedure in adults with known, intermediate-stage hepatocellular carcinoma (HCC).


HCC is the most common primary liver cancer and is the second biggest cause of death due to cancer worldwide
(1)
.

This medical device offers multiple advantages for healthcare professionals:

  • 24 hours Lipiodol
    ®
    resistance.  
  • Patented 3-way stopcock with 4 connections offering possibility of "On-table mixing" (interventional radiologists have the possibility of remixing without disconnection from the micro-catheter, thus maximizing the safety during the intervention).
  • Unique ready-to-use set: all devices in one set.
  • User-friendly: Ergonomic and quick device set-up, improving cTACE procedures for physicians.

"Vectorio
®
has been developed in collaboration with international interventional radiologists to match their medical needs for accurate, user-friendly and safe solution during cTACE procedures. The development of these image-guided procedures is a top priority for Guerbet's Interventional franchise. We are committed to enhance liver cancer patients' prognosis and quality of life worldwide"
said Yves L'Epine, CEO of Guerbet.

Designed and manufactured in France, Vectorio
®
's commercial launch will start this fall in European countries, where Lipiodol
®
Ultra Fluid is registered for cTACE
(2)
. Vectorio
®
registration program is also planned in other countries where cTACE is indicated
(2)
for Lipiodol
®
Ultra Fluid.

Guerbet teams will present Vectorio
®
in specialized international congresses in the upcoming weeks, where experts will carry out interactive demonstrations (CIRSE, JFR.).

  

References

(1)
WHO - Globocan 2012 (IARC) Section of Cancer Surveillance (9/7/2014).

(2)
Countries in which cTACE indication is registered: France, Japan, South Korea, Austria, Peru, Turkey, Hungary, Czech Republic, Mongolia, Argentina, The Netherlands, Vietnam, Thaïland, Mexico & Brazil.

 


About Vectorio
®

Vectorio
®
is a sterile medical device set of class Is (CE 0459) intended to be used by healthcare professionals only. It is a Lipiodol
®
resistant mixing and injection system for Trans-Arterial Chemo-Embolization (cTACE) procedures. 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.

About Lipiodol® Ultra Fluid

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 conventional transarterial chemo-embolization (cTACE). The approved indications for Lipiodol® Ultra Fluid may vary according to countries. Please refer to local SmPC for further information.

About cTACE

Conventional transarterial chemo-embolization (cTACE) is a minimally invasive procedure which consists of mixing Lipiodol
®
Ultra Fluid with an anticancer drug and injecting this treatment trans-arterially in the liver as a loco-regional targeted chemotherapy. cTACE was first performed in Japan in 1982 and then used effectively throughout Asia, Europe, the Middle East and Africa, as well as North America.
 

About Guerbet

Guerbet is a pioneer in the contrast agent field with over 90 years' of experience and is one of the leaders in medical imaging worldwide. It offers a full range of pharmaceutical products, medical devices and services for X-ray (RX), Magnetic Resonance Imaging (MRI) scanners and Interventional Radiology Theranostics (IRT) to improve the diagnosis and treatment of patients. With 7% of its revenue and more than 200 employees dedicated to R&D, Guerbet invests heavily in research and innovation. Guerbet (GBT) is listed on Euronext Paris (Segment B - Mid Caps) and generated €776 million in revenue in 2016. For more information about Guerbet, visit
www.guerbet.com

  

Media Relations Contacts


Guerbet Global





Alize RP




Caroline Carmagnol & Wendy Rigal




+33 (0)1 44 54 36 66 / +33 (0)6 48 82 18 94




guerbet@alizerp.com





 

 





 




 





 



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The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.

Source: GUERBET via GlobeNewswire

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