Remake® is the final frontier of synthetic degradable filler. It is a homogeneous, cohesive and injectable hydrogel for medicai use that does not contain any component of animai origin. lt is a long lasting, totally degradable and safe filler that provides a durable and very natural cosmetic effect.

Composition

Remake® is a three-dimensional hydrogel containing 4% synthetic polymer polyethylen-glycol (PEG), in non-pyrogenic water.

Indications

Clinica! studies have shown that Remake® is an effective solution for soft tissues augmentation if a good support is required. This is also endorsed by the chemical and mechanical characteristics of the product.
Remake® can be used, for example, for the correction of nasolabial folds due to aging, as well as for cheeks correction.

Biological safety and efficacy tests

Both in vitro and in vivo tests, in accordance with the relevant regulations, have demonstrated that Remake® is highly biocompatible, pure, non-mutagenic, non-toxic, non-sensitizing and resistant to mechanical stresses:

  • Mechanical characterization: rheology and texture analysisln
  • In vitro cytotoxicity
  • In vivo implantation test
  • lntracutaneous reactivity test
  • Acute systemic toxicity test
  • Delayed hypersensitivity test
  • Bacterial reverse mutation assay (Ames test)
  • Degradation test

Long lasting effect

Thanks to its cross-linked structure and to the lack of specific tissue enzymes that metabolize it, Remake® is more resistant to degradation and has a longer lasting effect than degradable fillers based on hyaluronic acid.
Remake® is resistant to mechanical stress and it preserves the mechanical properties after injection, even if it maintains a ease of manipulation and injection. Once implanted, it undergoes a slow but complete degradation within a maximum of 2 years.

Natural feeling

The crosslinked polymeric chains of PEG form a three-dimensional structure that retains a large amount of non-pyrogenic water, assuring a softness comparable to that of surrounding tissues.

Certification

Medical device CE marked, according to DDM 93/42/EEC, manufactured by EUmaterials Srl.

Injection technique

The injection technique of Remake® is relatively simple, not very different from that usually used for the implantation of other subcutaneous fillers.
Once the injection site has been identified, the skin should be cleaned and disinfected prior to administration as a precautionary measure. Local anesthesia should be applied using the local nerve block technique (troncular).
The injection can be made following the onset of the anesthesia and after attaching securely the enclosed needles on the syringe luer-lock. Once the tip of the needle has been positioned in the area of correction, the gel can be extruded from the syringe by applying a firm pressure on the plunger. In arder to contro l the subcutaneous diffusion of the gel, a small pressure with the fingers of the contralateral hand should be applied o n the area concerned. Overcorrection should be avoided.

Remake® is a monophasic gel that, unlike hyaluronic acid, does not draw water from the surrounding tissue. The esthetic result of the correction is immediately visible and strictly dependent upon the quantity of materia! injected.
Remake® should be injected unti! the defect disappears according to the result expected, and the area concerned should be thoroughly massaged to ensure proper distribution of the product.
No additional correction is generally required before 10-12 months. There are no contraindications to apply an additional treatment even on the day following the first injection. However, use of Remake® in any person with active skin inflammation or infection in or near the treatment area should. be deferred unti! the inflammatory or infectious process has been controlled.

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