GUERBET - Vectorio® Registration in India, An Innovative Medical Device for cTACE Procedures
03 Décembre 2019 - 6:23PM
Vectorio® Registration in India, An
Innovative Medical Device for cTACE Procedures
Villepinte (France) – December 3th, 2019
- 06:00pm - Guerbet (GBT) announces that the Ministry of
Health & Family Welfare delivered registration for its
innovative conventional Trans-Arterial Chemo-Embolization (cTACE)
mixing and injection system, Vectorio®, in India.
Vectorio® is a set of Lipiodol® resistant
medical devices (1) 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 fourth biggest cause of death due to cancer worldwide
(2).
This medical device offers multiple advantages
for healthcare professionals:
- 24 hours Lipiodol® Ultra Fluid resistance (1).
- 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).
- 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 an accurate, user-friendly and safe
solution during cTACE procedure. Vectorio® has been developed to
answer the request of standardization to cTACE procedures by
physicians,” said Philippe Havard, Global Head of Marketing for
Interventional Imaging - HCC and VAE
Designed and manufactured in France, Vectorio®
‘s commercial launch started in September 2017 in European
countries. Today, Vectorio® is registered in 20 countries over the
world (3). Vectorio® registration program is running for all
countries where Lipiodol® Ultra Fluid is indicated for cTACE
(4).
References
- Test report (E17-41) – Verification report of the device’s
functionality after 24h exposure to Lipiodol
- WHO – Globocan 2018 (IARC) Global Cancer Observatory.
- Countries in which Vectorio® is registered for cTACE: EMEA
(Austria, Belgium, Czech Republic, Denmark, France, Hungary,
Ireland, Luxembourg, Portugal, Switzerland, The Netherlands,
Turkey), Americas (Argentina, Brazil, Mexico, Peru), Asia-Pacific
(Hong Kong, India, New Zealand, South Korea, Thailand, Vietnam).
Vectorio® is also registered for HCC imaging in Germany.
- 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, Brazil,
Mexico, Peru), Asia-Pacific (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.
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) procedures of multinodular
hepatocellular carcinoma, where Lipiodol® Ultra-Fluid was used as a
procedure visualizer (contrast agent), a drug vehicle (drug
carrier), and an embolic. 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, in which Lipiodol® Ultra-Fluid acts as a contrast
agent, a drug eluting vehicle and a dual arterio-portal transient
embolic (2). 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 more than 90 years' experience, and is a leader in
medical imaging worldwide. It offers a comprehensive range of
pharmaceutical products, medical devices and services for
diagnostic and interventional imaging, to improve the diagnosis and
treatment of patients. With 8% of revenue dedicated to R&D and
more than 200 employees distributed amongst its four centers in
France, Israel and the United States, Guerbet is a substantial
investor in research and innovation. Guerbet (GBT) is listed on
Euronext Paris (segment B – mid caps) and generated €790 million in
revenue in 2018. For more information about Guerbet, please visit
www.guerbet.com.
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