Vectorio – cTACE medical device

This page is intended to provide information where cTACE indication is registered. It is not intended for use in USA, France and UK.
In USA, Lipiodol® is indicated for Imaging of HCC during interventional radiological procedures. Please refer to your local SPC.

Efficacy & safety for improved
cTACE mixing & delivery

VECTORIO®

Lipiodol® – indication in HCC

Visualization, Localization and Vectorization during Trans‑Arterial Chemoembolization (TACE) of hepatocellular carcinoma (HCC) at intermediate stage, in adults

  • HCC etiology
    – Hepatitis B & C
    – Prolonged alcohol abuse
    – Non alcoholic steato hepatitis (NASH)
  • Conventional Trans Arterial Chemoembolization (cTACE)
    – cTACE = Lipiodol® TACE
    – Intratumor injection of Lipiodol® + anticancer agent
    – Complementary embolization with gelatin sponge or particles

LIPIODOL® – INDICATED TO FIGHT HCC

Intented Use

Vectorio® intended use

Lipiodol® Resistant Mixing & Injection System for conventional Trans-Arterial Chemo-Embolization (cTACE)

Lipiodol® Ultra Fluid – anticancer mixture should be performed with Vectorio®

Mixture preparation recommendations**

 

• Anticancer drug should be first pushed towards the syringe containing Lipiodol®
• Anticancer drug volume should be lower than Lipiodol® volume, ideally 1 drug volume to 2 Lipiodol® volumes
• Vigorous mixing of Lipiodol® & anticancer drug via the stopcock

Lipiodol® Ultra Fluid may be associated with various anticancer drugs

Anticancer drugs that may be associated with Lipiodol ® Ultra Fluid***
Cisplatin Doxorubicin Epirubicin Mitomycin
Anticancer drugs that may be associated with Lipiodol ® Ultra Fluid***
Cisplatin Doxorubicin
Anticancer drugs that may be associated with Lipiodol ® Ultra Fluid***
Epirubicin Mitomycin

*Guerbet recommends the use of Vectorio® to prepare and inject the mixture of Lipiodol® and anticancer drug
**Th. De Baère et al. Cardio. Vasc. Radiol. 2016
***The instructions and precautions for use relating to anticancer drugs must be strictly followed

Vectorio compounds

Vectorio® compounds

Function of Vectorio® has been validated for resistance to Lipiodol® up to 24h*

*Test report (E17-41) – Verification report of the device’s functionality after 24h exposure to Lipiodol®

 

A & B 20 mL mixing syringes (x2)

C Particle filter for Lipiodol® Ultra Fluid withdrawal (x1)

D Lipiodol® Ultra Fluid ampoule withdrawing straw (x1)

E *Lipiodol® Ultra Fluid vial spike (x1)

F 3-way stopcock with 4 connections (x1)

G Connector (x1)

H 1 mL injection syringe (x1)

I 3 mL injection syringe (x1)

The system does not contain:

  • Lipiodol® Ultra Fluid ampule or vial
  • Anticancer drug
  • Microcatheter
A & B

Mixing syringes (20 mL) – Design Aim – Making multiple mixes easy & safe

Particle filter for withdrawing Lipiodol®

Design Aim – Easy & safe to perform preparation

15μm filter retain glass particles that may be released when breaking ampoule

3-way stopcock with 4 connections-(Patented) – Design Aim – Easy & safe to perform operation

Raw materials – Strong & Resistant for cTACE use

Double female connector

Design Aim – Easy & safe to perform preparation

Transfer drug from the pharmaceutical preparation syringe to the mixing syringe of Vectorio®

1 mL & 3 mL injection syringes – Design Aim- Making injection easy & safe

cTACE mixture preparation

Play Video

Step1: Withdrawing

Play Video

Step 2: Mixing 2

Play Video

Step 3: Injecting

Lipiodol® Ultra fluid – anticancer drug mixture preparation using

1
WITHDRAWING

• Withdraw Lipiodol® Ultra Fluid and anticancer drug into the 2 mixing syringes
• Connect the mixing syringes to the 4 ports 3 way stopcock
• Anticancer drug should be first pushed towards the syringe containing Lipiodol®

2
MIXING

• Perform 20 vigorous back & forth movements to obtain an homogeneous mixture

3
INJECTING

• Connect stopcock to the microcatheter
• Lipiodol® Ultra Fluid + anticancer drug mixture ready to inject
• Possibility of remixing, refill within closed system (on-table mixing)

1
2
3
WITHDRAWING

• Withdraw Lipiodol® Ultra Fluid and anticancer drug into the 2 mixing syringes
• Connect the mixing syringes to the 4 ports 3 way stopcock
• Anticancer drug should be first pushed towards the syringe containing Lipiodol®

MIXING

• Perform 20 vigorous back & forth movements to obtain an homogeneous mixture

INJECTING

• Connect stopcock to the microcatheter
• Lipiodol® Ultra Fluid + anticancer drug mixture ready to inject
• Possibility of remixing, refill within closed system (on-table mixing)

1 WITHDRAWING

• Withdraw Lipiodol® Ultra Fluid and anticancer drug into the 2 mixing syringes
• Connect the mixing syringes to the 4 ports 3 way stopcock
• Anticancer drug should be first pushed towards the syringe containing Lipiodol®

2 MIXING

• Perform 20 vigorous back & forth movements to obtain an homogeneous mixture

3 INJECTING

• Connect stopcock to the microcatheter
• Lipiodol® Ultra Fluid + anticancer drug mixture ready to inject
• Possibility of remixing, refill within closed system (on-table mixing)

The cTACE mixture should be extemporaneously prepared and should be used immediately after preparation.

Features & benefits of Vectorio®

Features

Lipiodol® resistant & Unbreakable

Benefits

• Safety – Closed system to reduce risks of leakage 
• Swiftness – No devices break & no devices change

Features

Ergonomic & User-Friendly
• Syringe back stop
• Rotary finger grip
• Optimized-handling

Benefits

• Safety – No syringe pull-back & no liquids projection
• Accuracy – Easy-to-handle & sharp
• Swiftness – Easy-to-mix & easy-to-inject
• Convenience – Ready-to-use

Features

3W4p* stopcock system
• Unique 3-way 4 Ports stopcock
• Ports safe-guards
• Closed system

Benefits

• Safety – Reduced risks of infection, air injection, leaks
• Swiftness – less connection mistakes & no disconnection time
• Convenience – On-table Mixing & optimized injection control

Documentation

You are welcome to consult and read the following online version of our brochures, bibliography and CCDS

LIPIODOL® ULTRA-FLUID.
Composition
: Ethyl esters of iodized fatty acids of poppy seed oil 10 mL, corresponding to an iodine content of 480 mg/mL. Indications (**): In diagnostic radiology – Hysterosalpingography – Ascending urethrography – Lymphography – Sialography – Fistulography and exploration of abscesses – Exploration of frontal sinuses – Pre and post-operative cholangiography. In interventional radiology – Visualisation and localization (by selective intra-arterial use during CT) of liver  lesions in adults with known or suspected hepatocellular carcinoma – Visualisation, localisation and vectorisation during Trans-Arterial Chemo-Embolisation (TACE) of hepatocellular carcinoma at intermediate stage, in adults – Selective embolization in combination with Histoacryl glue (particularly for arteriovenous malformation or aneurysms) – Selective injections of LIPIODOL ULTRA-FLUID into the hepatic artery for diagnostic purposes where a spiral CT scan is not practical. In endocrinology – Prevention of severe cases of iodine deficiency. Posology and method of administration (*): have to be adapted according to the type of examination, the territories explored, the age and weight of the patient. The volume to be administered depends on the particular requirements of the technique and the size of the patient. Contraindications: Hypersensitivity to LIPIODOL ULTRA-FLUID – Confirmed hyperthyroidism – Patients with traumatic injuries, recent haemorrage or bleeding – Hysterosalpingography during pregnancy or acute pelvic inflammation – Bronchography. In interventional radiology (Trans-Arterial Chemo-Embolization), Administration in liver areas with dilated bile ducts unless drainage has been performed. Special warnings and special precautions for use (*): There is a risk of hypersensitivity regardless of the dose administered.  Lymphography:  Pulmonary embolism may occur immediately or after few hours to days from inadvertent systemic vascular injection or intravasation of LIPIODOL ULTRA-FLUID: Perform radiological monitoring during LIPIODOL ULTRA-FLUID injection and avoid use in patients with severely impaired lung function, cardiorespiratory failure or right-sided cardiac overload.  Hypersensitivity: all iodinated contrast agents can lead to minor or major hypersensitivity reactions, which can be life-threatening. These hypersensitivity reactions are of an allergic nature (known as anaphylactic reactions if they are serious) or a non-allergic nature. They can be immediate (occurring within 60 min) or delayed (not occurring until up to 7 days later). Anaphylactic reactions are immediate and can be fatal. They are dose-independent, can occur right from the first administration of the product, and are often unpredictable: avoid use in patients with a history of sensitivity to other iodinated contrast agents, bronchial asthma or allergic disorders because of an increased risk of a hypersensitivity reaction to LIPIODOL ULTRA-FLUID. Thyroid: can cause hyperthyroidism in predisposed patients. Lymphography saturates the thyroid with iodine for several months and thyroid exploration should be performed before radiological examination.  Chemo-Embolization: Trans-Arterial Chemo-Embolization is not recommended in patients with decompensated liver cirrhosis (ChildPugh ≥8), advanced liver dysfunction, macroscopic invasion and/or extra-hepatic spread of the tumour. Renal insufficiency must be prevented by correct rehydration before and after the procedure. Oesophageal varices must be carefully monitored. Hepatic intra-arterial treatment can progressively cause an irreversible liver insufficiency in patients with serious liver malfunction and/or undergoing close multiple sessions. The risk of superinfection in the treated area is normally prevented by administration of antibiotics. Embolization with glue: An early polymerisation reaction may exceptionally occur between LIPIODOL ULTRA-FLUID and certain surgical glues, or even certain batches of glue. Before using new batches of LIPIODOL ULTRA-FLUID or surgical glue, the compatibility of LIPIODOL ULTRA-FLUID and the glue must be tested in vitro. Interaction with other medicinal products and other forms of interaction (*): Metformin, Beta blockers, vasoactive substances, angiotensin-converting enzyme inhibitors, angiotensin-receptor antagonists, Diuretics, Interleukin II. Fertility, pregnancy and lactation (*): LIPIODOL ULTRA-FLUID must only be used in pregnant women if absolutely necessary and under strict medical supervision. Breastfeeding should be discontinued if LIPIODOL ULTRA-FLUID must be used – Effects on ability to drive and use machines: The effects on ability to drive and to use machines have not been investigated – Undesirable effects (*): Most adverse effects are dose-related and dosage should therefore be kept as low as possible :hypersensitivity, anaphylactic reaction, anaphylactoid reaction, vomiting, diarrhea, nausea, fever, pain, dyspnea, cough, hypothyroidism, hyperthyroidism, thyroiditis, pulmonary embolism, cerebral embolism, retinal vein thrombosis, lymphoedema aggravation, hepatic vein thrombosis, granuloma. Overdose (*): The total dose of LIPIODOL ULTRA-FLUID administered must not exceed 20 mL – Pharmacodynamic properties (*): Pharmacotherapeutic group: X-ray contrast media, iodinated; ATC code: V08A D01. Water-insoluble iodinated contrast medium. Presentation (**):
10 mL glass ampoule. Marketing authorization holder (*): Guerbet – BP 57400 – F-95943 Roissy CdG cedex – FRANCE. Information: tel: 33 (0) 1 45 91 50 00. Revision: April 24th, 2018.

(*) For complete information please refer to the local Summary of Product Characteristics
(**) Indications, volumes and presentations may differ from country to country.

Reporting of suspected adverse reactions is important as it helps to continuously assess the benefit-risk balance. Therefore, Guerbet encourages you to report any adverse reactions to your health authorities or to our local Guerbet representative.

Countries in which cTACE indication is registered: Austria, Argentina, Belgium, Brazil, Cambodia, Czech Republic, Denmark, France,  Hong Kong, Hungary, Ireland, India, Iran, Luxembourg, Mexico, Mongolia,  New Zealand, Peru, Portugal, Philippines, South Korea, Sri Lanka, Switzerland, Turkey, The Netherlands, Thailand, Taiwan, Tunisia, Vietnam.
Country in which adjustment of drugs or medical devices is registered: Japan.
For a copy of the SPC, please contact a member of Guerbet.

VECTORIO® is a medical device of Class Is (CE 0459) intended to be used by healthcare professionals only. Manufacturer: Medex, a Guerbet Group company. Intended use: Lipiodol® Resistant Mixing & Injection System for conventional Trans-Arterial Chemo-Embolization (cTACE).
For complete information please refer to country’s local Package Information Leaflet & Vectorio® Instruction For Use (IFU).

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