Fillmed Art Filler Volume 2x1.2ml
Important Notice
Regulated medical device (EU MDR 2017/745). For sale exclusively to qualified healthcare professionals.
What this purchase includes
- Original productFrom the manufacturer or an official distributor, CE marked.
- Batch and expiry documentedRecorded per unit on the delivery note and the invoice.
- Controlled storageOur own Madrid warehouse, 12 to 18 °C under 24 h control.
- Dispatch in 24 to 48 hFrom Madrid, insured and with a tracking number.
- Reachable Monday to Friday9:00 to 17:00 by WhatsApp and email. People, not forms.
FILLMED ART FILLER® VOLUME is the volumising reference of the ART FILLER® range: a cross-linked hyaluronic acid gel at 25 mg/g with lidocaine 3 mg/g and TRI-HYAL® technology, formulated to work in the deep plane — deep dermis, subcutaneous or supraperiosteal. Its indication is the structural restoration of the middle third, the chin, the mandibular angle and the temples, not the correction of superficial wrinkles.
- Cross-linked HA 25 mg/g
- Lidocaine 3 mg/g (0.3 %)
- Contents 2 syringes × 1.2 ml
- Needles 4 × 27G ½"
- Resorption 12–18 months
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 formulation combines three hyaluronic acid fractions of different molecular weight:
| Very long chains 3.7–4.5 × 10⁶ Da | Sculpting potential: the moulding capacity of the gel 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 |
In ART FILLER® VOLUME the proportion is weighted towards the long and very long chains, so that the gel withstands the load of the overlying tissues and maintains projection in the deep plane. This is the reason why, with the same hyaluronic acid concentration as UNIVERSAL, its indication and its injection plane are different.
Sterilisation: syringe contents by moist heat; needles by irradiation.
Position within the ART FILLER® range
| Fine Lines | HA 20 mg/ml · 2 × 1 ml · 4 needles 30G ½" — superficial wrinkles and fine lines |
|---|---|
| Universal | HA 25 mg/ml · 2 × 1.2 ml · 4 needles 27G ½" — moderate to deep wrinkles; deep dermis |
| Volume | HA 25 mg/ml · 2 × 1.2 ml · 4 needles 27G ½" — facial volume; deep, subcutaneous or supraperiosteal plane |
| Lips | HA 25 mg/ml · 2 × 1 ml · 4 needles 27G ½" — lip volume and definition |
| Lips Soft | HA 25 mg/ml · 1 × 1 ml · 2 needles 30G ½" — soft lip volume and perioral wrinkles |
All the references contain lidocaine at 0.3 %. The range also includes ART FILLER® Eyes for the periorbital area. The difference between VOLUME and UNIVERSAL lies not in the concentration but in the rheology and in the working plane: VOLUME is contraindicated in the lips and in the ocular area, areas that UNIVERSAL does partly cover.
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: restoration of facial volume and correction of the structural changes associated with age.
- Middle third and malar region
- Mandibular angle and jawline
- Temples
- Chin
Must not be injected into superficial lines, the lips, the periocular area, blood vessels or muscle.
Technique and treatment protocol
Injection plane: deep dermis, subcutaneous or supraperiosteal plane, according to the area treated.
Instruments: 27G ½" needles included in the pack; the manufacturer accepts as an alternative a sterile cannula of 22G ½" to 25G ½".
Maximum doses per session indicated by the manufacturer:
| Middle third and chin | 2.4 ml |
|---|---|
| Jawline and temples | 1.2 ml |
| Annual maximum | 15 ml |
| Frequency | Up to 2 sessions per year |
Duration: the manufacturer estimates resorption of the product at between 12 and 18 months. The clinical study reported by FILLMED for this reference was conducted in 98 subjects.
Periprocedural precautions: avoid acetylsalicylic acid and high-dose vitamins in the preceding week; avoid 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, subcutaneous or supraperiosteal |
| Resorption | Between 12 and 18 months |
| 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.
- 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; active inflammation or infection in the treatment area.
Excluded areas: superficial lines, lips, periocular area, blood vessels and muscle.
Vascular warning: accidental intravascular injection may cause embolisation with a risk of visual disturbance, blindness, stroke or tissue necrosis. The manufacturer draws particular attention to the glabellar and periorbital regions. Apply aspiration and retrograde injection 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® VOLUME 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.