Guerbet Announces CE Mark for Vectorio®, An Innovative Medical Device for cTACE Procedures
September 14 2017 - 12:02PM
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.
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.
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.
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
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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information contained therein.
Source: GUERBET via Globenewswire
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