Aliaxin EV Essential Volume 2x1ml
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.
ALIAXIN® EV Essential Volume from IBSA Derma is the volumising filler of the Aliaxin range intended for the deep subcutaneous plane. It contains 25 mg/ml of cross-linked hyaluronic acid plus 2.5 mg/ml of free hyaluronic acid, with chains of 1,000 and 2,000 kDa. Its elasticity value (162 Pa) places it between GP and SV: it provides volumetric support without the rigidity of a maximum-projection filler.
- Cross-linked HA 25 mg/ml
- Free HA 2.5 mg/ml
- Contents 2 syringes × 1 ml
- Needles 2 × 27G 13 mm + 2 × 27G 19 mm
- Plane deep subcutaneous
Composition and technology
- Cross-linked hyaluronic acid: 25 mg/ml, of non-animal origin, obtained by bacterial fermentation.
- Free (non-cross-linked) hyaluronic acid: 2.5 mg/ml. It provides lubrication during injection and immediate hydration of the tissue, and integrates the product into IBSA's Hydrolift® Action concept.
- Molecular weights: combination of 1,000 kDa and 2,000 kDa chains.
- Cross-linking with BDDE at a low percentage: degree of cross-linking below 10 %, with a BDDE residue below 0.1 ppm. A lightly cross-linked gel is easier to inject and integrates better into the tissue; the duration is sustained by the quality of the raw material rather than by the density of the network.
- SHYALT technology: IBSA's proprietary method for obtaining ultrapure hyaluronic acid, the basis of the entire Aliaxin range.
- Rheological profile: elasticity (lift) 162 Pa; flow 0.15; sculpt 0.10.
- The formulation does not include a local anaesthetic.
Differences between the references in the Aliaxin range
| Aliaxin FL — Fine Lines | 25 mg/ml; 500 + 1,000 kDa; lift 45 Pa — mid/deep dermis: fine lines, lip contour, perioral wrinkles |
|---|---|
| Aliaxin GP — Global Performance | 25 mg/ml; 1,000 + 2,000 kDa; lift 95 Pa — deep dermis/subcutaneous: nasolabial fold, glabella, marionette lines, malar and chin volume |
| Aliaxin EV — Essential Volume | 25 mg/ml; 1,000 + 2,000 kDa; lift 162 Pa — deep subcutaneous: zygomatic region, jawline, temples |
| Aliaxin SV — Superior Volume | 25 mg/ml; 2,300 kDa; lift 295 Pa — deep/supraperiosteal plane: cheekbones, mandibular angle, chin |
| Aliaxin LV — Lips Volume | 25 mg/ml; 1,000 + 2,000 kDa — labial submucosa: lip volumising |
The five references share the same hyaluronic acid concentration (25 mg/ml cross-linked + 2.5 mg/ml free). What differentiates them is the combination of molecular weights and the resulting rheological behaviour, which determines the injection plane and the indication.
Indications and treatment areas
Injectable implant indicated for volumetric restoration and the correction of deep facial ptosis.
- Zygomatic region and cheekbones
- Jawline and redefinition of the facial oval
- Temples (deep plane)
- Markedly deep nasolabial fold
- Chin and post-traumatic or acne scar depressions requiring filling of the deep compartment
Technique and treatment protocol
- Injection plane: deep subcutaneous tissue, in the deep fat compartment.
- Needles included: 2 × 27G × 13 mm and 2 × 27G × 19 mm.
- Technique: bolus deposit or linear retrograde injection according to the area; application with a cannula is also possible in experienced hands.
- Aspiration and retrograde injection in accordance with the usual clinical protocol to minimise vascular risk.
- Never inject intravascularly. Do not apply in areas with permanent implants.
- Do not combine in the same session with laser, deep peeling or dermabrasion.
- The amount and the number of sessions are determined according to the degree of correction sought and the individual response.
Technical data
| Manufacturer | IBSA Derma — IBSA Institut Biochimique SA, Switzerland |
|---|---|
| Active substance | Cross-linked hyaluronic acid 25 mg/ml + free hyaluronic acid 2.5 mg/ml |
| Molecular weights | 1,000 kDa and 2,000 kDa |
| Cross-linker | BDDE — degree of cross-linking < 10 %, residue < 0.1 ppm |
| Technology | SHYALT (ultrapure hyaluronic acid); Hydrolift® Action |
| Rheological profile | Lift 162 Pa; flow 0.15; sculpt 0.10 |
| Anaesthetic | Not contained |
| Presentation | 2 pre-filled syringes of 1.0 ml |
| Needles | 2 × 27G × 13 mm + 2 × 27G × 19 mm |
| Application plane | Deep subcutaneous |
| Classification | Medical device with CE marking |
| Use | Qualified healthcare professionals only |
Storage and pack contents
- Storage: between 2 °C and 25 °C, in a dry place protected from direct sunlight. Do not freeze.
- Do not use after the expiry date shown on the packaging.
- Single-use product. Do not reuse or resterilise.
- The pack contains: 2 pre-filled syringes of 1.0 ml in a sterile blister, 4 sterile needles (2 × 27G × 13 mm and 2 × 27G × 19 mm), package leaflet and adhesive traceability labels for the patient record.
Contraindications and warnings
Contraindications: known hypersensitivity to hyaluronic acid or to any of the components; active skin infection or inflammation in the treatment area, including active herpes simplex or acne in the inflammatory phase; tendency to hypertrophic or keloid scarring; autoimmune diseases; coagulation disorders or anticoagulant or antiplatelet therapy; pregnancy and breastfeeding; under 18 years of age.
Warnings: do not inject intravascularly, intramuscularly or into tendons. Do not mix with other products in the same syringe. Do not apply over areas previously treated with permanent implants. Individual assessment in immunocompromised patients or in those with a history of multiple allergies.
Always consult the instructions for use included in the pack before application. The binding contraindications are those set out in the official documentation accompanying the product.
Medical device intended exclusively for qualified healthcare professionals. Technical information based on the official documentation of IBSA Derma. This data sheet does not replace the instructions for use accompanying the product.