Frequently Asked Questions

 

No, the VARIXIO system is designed to produce a foam with standardised physical characteristics. Re-use would mean unknown residual volumes of the sclerosant liquid and the gas that would form the foam, and would also break the conditions of sterility. In addition, the materials used to make VARIXIO capsules are chosen based on single use. With repeated use they may undergo degradation, affecting the function and safety of the device.

For VARIXIO Pod Air units manufactured from 01/2025 onwards, the top seal has been changed and is now made of Tyvek and should not be removed.

For VARIXIO Pod Air units manufactured before 01/2025, the metallic operculum on the top must be removed before adding the sclerosant, following the instructions in the original Instructions for Use.

The VARIXIO Pod Low N2 also has a Tyvek top seal that should not be removed. However, it includes a small seal on the loading point that must be removed before introducing the sclerosant.

NOTE: Please always refer to the Instructions for Use (IFU) included in the product box to ensure correct handling for your specific lot.

Yes, but 2-piece syringes maintain foam stability better. If using a 3-piece syringe, you should choose an appropriate brand and bear in mind that STS foam is much less stable and greatly affected by silicone content. In this situation, 5 mL syringes perform better than 10 mL syringes.

It must be taken into account that the 2 and 5 mL 3-piece syringes have little friction, so when the sclerosant is introduced into the VARIXIO Pod capsule, its plunger may go back (due to the overpressure generated inside the capsule) can cause the unintentional aspiration (back into the syringe) of up to 0.5 mL of sclerosant, that is, 25% of the capsule load. This circumstance could affect the quality and volume of foam manufactured. In no case would it affect the safety of the patient.

To avoid this effect when using 3-piece syringes of 2, 5 or 10 mL, we suggest considering the following alternative use:

New VARIXIO Pod Air (Tyvek top seal, from 2025 onward) and VARIXIO Pod Low N2: The top seal should not be removed. If you experience unintentional aspiration when using 3-piece syringes, inject the sclerosant slowly to minimize this effect.
Previous VARIXIO Pod Air (metallic top seal, before 2025): It is recommended to remove the metallic operculum before introducing the sclerosant. Doing so helps prevent unintentional aspiration.

Yes, but we do not recommend it because a 2 mL syringe will require repeated reloading as the procedure progresses. While the VARIXIO Pro Mag stirrer is in “aspirate” mode (syringe icon on the display) it is very important to cover the aspiration outlet with the cap to avoid contamination and/or sclerosant leakage from the capsule.

In particular, the 2 mL 3-piece syringes have little friction, so when the sclerosant is introduced into the VARIXIO Pod capsule, its plunger can go back (due to the overpressure generated inside the capsule), which can cause unintentional aspiration (back into the syringe) of up to 0.5 mL of sclerosant, i.e. 25% of the capsule load. This circumstance could affect the quality and volume of foam manufactured. In no case would it affect the safety of the patient.

To avoid this effect when using syringes of small volumes, we suggest considering the following alternative use:

New VARIXIO Pod Air (Tyvek top seal, from 2025 onward) and VARIXIO Pod Low N2: The top seal should not be removed. If you experience unintentional aspiration when using 3-piece syringes, inject the sclerosant slowly to minimize this effect.
Previous VARIXIO Pod Air (metallic top seal, before 2025): It is recommended to remove the metallic operculum before introducing the sclerosant. Doing so helps prevent unintentional aspiration.

Yes. Depending on the quantity of foam previously withdrawn, it will produce a foam with slightly different characteristics. It is recommended to adhere to the maximum total injection volume of 10 mL (VARIXIO Pod Air) and 15 mL (VARIXIO Pod Low N2).

The VARIXIO system is designed so that in the worst-case scenario, the resulting foam will be suboptimal but will never present a risk for the patient. Two extreme situations may occur:

A) Incorrect use of the maximum speed and time. Selection of (Low N2/POL/<1%) instead of (Air/STS/>0.5%). This will result in an abundant, dry foam. As the recommendation is to aspirate 9 mL, this should not go beyond the quantity of air recommended in the clinical guidelines.

B) Incorrect use of the minimum speed and time. Selection of (Air/STS/>0.5%) instead of (Low N2/POL/<1%). This will result in a stable foam with a gas-to-liquid ratio of around 4:1, the ratio recommended in the Tessari method. The foam will be less stable but within the parameters suggested in the clinical guidelines.

Yes. The stirring speed in “aspiration” mode (syringe icon on the display) is not the predetermined mode to generate an optimal foam with the desired bubble size and gas-to-liquid ratio, but it goes emulsify and homogenise the foam. To obtain the desired characteristics, it is recommended to start the process from the beginning with 2 mL of liquid.

Yes, but quantification of such mixes has not been performed, and given the variability of possible mixes, it is recommended to use a maximum of 2 mL, which would generate a total foam volume < 12 mL. This would not exceed the recommendations in the clinical guidelines.

Yes. To avoid the inadvertent entry of air and to obtain maximum foam homogeneity in the syringe, it is suggested to carefully aspirate around 1 mL per second, keeping the syringe firmly connected to the capsule. It may be helpful to use the opposite hand to hold the capsule in its docking site to avoid it moving.

Currently there are only in vitro studies describing the physical characteristics of microfoam prepared with VARIXIO.

Assuming that the stability of the foam favours the effectiveness of the sclerosing product, VARIXIO offers a microfoam which, in terms of bubble diameter, versatility and half life, is superior to that prepared with manual methods.

The convenience of use and standardisation of the procedure are tools that may favour treatment results, even though the application method and strategy will depend on the professional.

Follow the recommendations below:

  • Unplug the device.
  • Make sure there is no capsule attached.
  • Clean device of debris.
  • Store the device in its original packaging or in a box.
  • The storage location must meet the following parameters:
    – Temperature: between 5°C and 40°C
    – Max. humidity: 80% relative humidity
  • After prolonged storage in a cold environment, condensation may occur inside the unit when it is brought into its place of operation. Wait at least 1 hour for the device to reach room temperature and dry out before switching it on.

If you need more information or you have further questions, please don’t hesitate to contact our support team support@varixio.com

  • Check that the parameters selected on the display match the type of gas in the capsule (Air/Low N2), the type of sclerosant (STS/POL) and concentration:
  • With 2 mL of sclerosant, the resulting foam has a ratio of 1:5-1.7, with a half-life of 5 minutes. Entering more or less volume makes the ratio vary. In wet foams the bubbles are spherical and quickly separate due to excess liquid. In dry foams, the bubbles are polyhedral and stay together longer.
  • Higher concentration foams are more stable than lower concentration ones.
  • POL foams are more stable than STS.
  • Foams with atmospheric air are more stable than those with physiological gases.
  • Accidental program interruptions for any reason may result in suboptimal foam.
  • For VARIXIO Pod Air, manufactured before 01/2025:
    • Do not remove the upper metallic operculum until the manufacturing program is finished.
    • It is necessary to open the operculum to remove the foam.
    • Failure to do so results in a large initial bubble that is very obvious to the eye.
  • It is advisable to aspirate by keeping the syringe firmly connected with the capsule and at a constant rate of 1 mL per second, to avoid the inadvertent entry of air and to obtain maximum homogeneity of the foam in the syringe.
  • The temperature of the room and the sclerosant, recommended below 25ºC, has a direct effect on the stability of the foam.
  • The component to dilute: Normal saline is recommended because it does not interfere with or affect the sclerosing agent and its injection is painless and safe, with no harmful effect on intravenous injection. Glycerin as a non-sclerosing detergent agent can be used together with physiological saline as a foam stability enhancer (35%).
  • The type of syringe: Those that provide from greater to lesser stability are; glass, two-part plastic, three-part plastic without silicone.
  • The use of 5 micron filters provides an increase in homogeneity.

If you need more information or have further questions, please don’t hesitate to contact us. support@varixio.com

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