Fillmed Art Filler Universal 2x1.2ml
Important Notice
Medical device regulated by the European Medical Device Regulation (MDR), intended exclusively for authorized healthcare professionals. By purchasing, the customer declares to be authorized for their professional activity; false information may entail legal responsibilities.
FILLMED ART FILLER® UNIVERSAL is the versatile filler of the ART FILLER® range: a cross-linked hyaluronic acid gel at 25 mg/g with lidocaine 3 mg/g, built on TRI-HYAL® technology, which combines three hyaluronic acid fractions of different molecular weight. It is indicated for moderate and deep wrinkles and for the restoration of volume in the middle third, with injection into the deep dermis using a needle or cannula.
- Cross-linked HA 25 mg/g
- Lidocaine 3 mg/g (0.3 %)
- Contents 2 syringes × 1.2 ml
- Needles 4 × 27G ½"
- Technology TRI-HYAL®
Composition and TRI-HYAL® technology
Composition per gram of gel:
| Cross-linked sodium hyaluronate | 25 mg/g |
|---|---|
| Lidocaine hydrochloride | 3 mg/g (0.3 %) |
| Vehicle | Phosphate buffer solution, pH 6.50–7.50 |
| Cross-linking agent | BDDE — residual content < 2 ppm |
TRI-HYAL® — three hyaluronic acids, three correction potentials. The manufacturer formulates the gel with three hyaluronic acid fractions that act in a complementary manner:
| Very long chains 3.7–4.5 × 10⁶ Da | Sculpting potential: moulding capacity, the gel allows itself to be shaped in the tissue |
|---|---|
| Long chains 1.0–1.5 × 10⁶ Da | Volumising potential: elasticity and resistance to deformation |
| Free hyaluronic acid | Smoothing potential: viscosity and tissue integration |
The proportion between the three fractions is adjusted in each reference of the range, which explains why products with the same hyaluronic acid concentration have different rheological behaviour and indications.
Sterilisation: syringe contents by moist heat; needles by irradiation.
Position within the ART FILLER® range
| Fine Lines | HA 20 mg/ml · lidocaine 0.3 % · 2 × 1 ml · 4 needles 30G ½" — superficial wrinkles and fine lines |
|---|---|
| Universal | HA 25 mg/ml · lidocaine 0.3 % · 2 × 1.2 ml · 4 needles 27G ½" — moderate to deep wrinkles and volume of the middle third |
| Volume | HA 25 mg/ml · lidocaine 0.3 % · 2 × 1.2 ml · 4 needles 27G ½" — volumetric restoration in the deep plane |
| Lips | HA 25 mg/ml · lidocaine 0.3 % · 2 × 1 ml · 4 needles 27G ½" — lip volume and definition |
| Lips Soft | HA 25 mg/ml · lidocaine 0.3 % · 1 × 1 ml · 2 needles 30G ½" — soft lip volume and perioral wrinkles |
The range also includes the reference ART FILLER® Eyes for the periorbital area. Universal and Volume share concentration, presentation and needle gauge: they differ in their rheological profile and, above all, in the injection plane — Universal works in the deep dermis and labial mucosa, Volume in the supraperiosteal or subcutaneous plane.
This retailer does not distribute all the references in the range; the table is offered solely as technical guidance.
Indications and treatment areas
Indications according to the manufacturer:
- Nasolabial folds
- Marionette lines
- Malar folds
- Nasal definition
- Restoration of volume in the middle third
- Augmentation of lip volume and definition of the lip contour
Must not be injected into superficial lines, into the periocular area or into blood vessels, bone, tendons or ligaments.
Technique and treatment protocol
Injection plane: deep dermis or labial mucosa.
Instruments: 27G ½" needles included in the pack; the manufacturer accepts as an alternative a cannula of 22G ½" to 25G ½".
Maximum doses per session indicated by the manufacturer:
| Middle third | 2.4 ml |
|---|---|
| Lips | 1.0 ml per lip |
| Other areas | 1.2 ml |
| Annual maximum | 15 ml |
| Frequency | Up to 2 sessions per year |
Duration: the manufacturer's data sheet estimates resorption of the product at between 6 and 12 months. The clinical studies reported by FILLMED for the ART FILLER® range document results of up to 18 months (study on ART FILLER® Universal with 31 subjects).
Periprocedural precautions: the manufacturer recommends avoiding acetylsalicylic acid and high-dose vitamins during the preceding week, and avoiding sun exposure and extreme temperatures during the following two weeks.
Technical data
| Manufacturer | Laboratoires FILL-MED, Paris, France |
|---|---|
| Active substance | Cross-linked sodium hyaluronate 25 mg/g |
| Anaesthetic | Lidocaine hydrochloride 3 mg/g (0.3 %) |
| Cross-linker | BDDE, residual < 2 ppm |
| Molecular weights | 1.0–1.5 × 10⁶ Da (long chain) and 3.7–4.5 × 10⁶ Da (very long chain) |
| Technology | TRI-HYAL® |
| pH | 6.50–7.50 (phosphate buffer) |
| Presentation | 2 pre-filled syringes of 1.2 ml |
| Needles | 4 × 27G ½" |
| Sterilisation | Moist heat (syringe) / irradiation (needles) |
| Injection plane | Deep dermis or labial mucosa |
| Classification | Injectable medical device with CE marking |
| Use | Qualified healthcare professionals only |
Storage and pack contents
- Storage: between 5 °C and 25 °C, in a dry place, protected from light and from humidity.
- Single-use product. Do not reuse or resterilise.
- Do not use after the expiry date shown on the packaging.
- The pack contains: 2 pre-filled syringes of 1.2 ml, 4 needles 27G ½", instructions for use and traceability labels.
Contraindications and warnings
Contraindications: under 18 years of age; pregnancy and breastfeeding; known hypersensitivity to hyaluronic acid or to lidocaine; autoimmune disease or ongoing immunotherapy; severe allergies; uncontrolled epilepsy; porphyria; tendency to hypertrophic or keloid scarring; active inflammation or infection in the treatment area.
Excluded areas: superficial lines, periocular area, blood vessels, bone, tendons and ligaments.
Vascular warning: accidental intravascular injection may cause embolisation with a risk of visual disturbance, blindness, stroke or tissue necrosis. Apply the aspiration and retrograde injection technique in accordance with the clinical protocol.
Always consult the instructions for use included in the pack before application.
Medical device intended exclusively for qualified healthcare professionals. Technical information based on the official documentation of Laboratoires FILL-MED (information leaflet for healthcare professionals ART FILLER® UNIVERSAL in accordance with the MDR and the technical brochure of the ART FILLER® range). This data sheet does not replace the instructions for use accompanying the product.