Aliaxin SV Superior 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® SV Superior Volume from IBSA Derma is the filler with the greatest projection capacity in the Aliaxin range. With 25 mg/ml of cross-linked hyaluronic acid, 2.5 mg/ml of free hyaluronic acid and a 2,300 kDa chain, it reaches an elasticity value of 295 Pa — the highest in the line — intended for the deep plane for the reconstruction of bony structures and of the facial contour.
- Cross-linked HA 25 mg/ml
- Free HA 2.5 mg/ml
- Elasticity 295 Pa
- Contents 2 syringes × 1.1 ml
- Needles 2 × 27G 13 mm + 2 × 27G 19 mm
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, for lubrication during injection and immediate hydration of the tissue.
- Molecular weight: 2,300 kDa, the highest in the range. The long chains are the basis of the structural behaviour of the gel.
- Cross-linking with BDDE at a low percentage: degree of cross-linking below 10 %, with a BDDE residue below 0.1 ppm. In SV the projection does not come from dense cross-linking, but from the chain length and the architecture of the gel.
- SHYALT technology: IBSA's proprietary method for obtaining ultrapure hyaluronic acid.
- Rheological profile: elasticity (lift) 295 Pa; flow 0.12; sculpt 0.08. High projection capacity and low fluidity: the product remains localised where it is deposited.
- Phosphate buffer to maintain the physiological pH. 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. SV is the only one with a single 2,300 kDa chain and the only product in the range designed for the supraperiosteal plane.
Indications and treatment areas
Injectable implant indicated for the correction of significant volumetric deficits and the structural redefinition of the facial contour.
- Cheekbones and zygomatic region — projection of the middle third
- Mandibular angle and jawline
- Chin and profile projection
- Deep nasolabial fold and marked marionette lines
Because of its elasticity, SV is not indicated for work in the superficial dermis or for the lips: in those planes FL, GP or LV should be used according to the area.
Technique and treatment protocol
- Injection plane: deep subcutaneous or supraperiosteal plane, according to the area treated.
- Needles included: 2 × 27G × 13 mm and 2 × 27G × 19 mm.
- Technique: deep bolus deposit onto the periosteum at projection points; linear retrograde injection with a cannula for the jawline.
- 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 weight | 2,300 kDa |
| Cross-linker | BDDE — degree of cross-linking < 10 %, residue < 0.1 ppm |
| Technology | SHYALT (ultrapure hyaluronic acid); Hydrolift® Action |
| Rheological profile | Lift 295 Pa; flow 0.12; sculpt 0.08 |
| Anaesthetic | Not contained |
| Presentation | 2 pre-filled syringes of 1.1 ml |
| Needles | 2 × 27G × 13 mm + 2 × 27G × 19 mm |
| Application plane | Deep subcutaneous / supraperiosteal |
| 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. Ready for use, it does not require reconstitution.
- The pack contains: 2 pre-filled syringes of 1.1 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.