Stylage Hydro Max 1x1ml
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.
STYLAGE® HydroMax is the injectable revitaliser from Laboratoires VIVACY for improving skin hydration and elasticity: 12.5 mg of BDDE cross-linked hyaluronic acid per gram of gel. Unlike the rest of the STYLAGE range, it is not formulated with mannitol but with sorbitol as the moisturising agent. It is injected into the mid to deep dermis of the face, neck, décolletage and dorsum of the hand.
- Cross-linked HA 12.5 mg/g (BDDE)
- Active excipient Sorbitol (moisturising agent)
- Contents 1 syringe × 1.0 ml
- Needles 2 sterile single-use
- Protocol 1 to 3 sessions
Composition and technology
- Cross-linked hyaluronic acid (BDDE): 12.5 mg.
- Phosphate buffer and sorbitol, pH 7.2, q.s. to 1 g of gel.
- Sorbitol, not mannitol: the instructions for use describe STYLAGE® HydroMax as a cross-linked hyaluronic acid gel incorporating a moisturising agent (sorbitol). It is the only reference in the range that does not contain mannitol as an antioxidant. This difference in formulation has a direct clinical consequence: HydroMax is contraindicated in patients with fructose intolerance.
- Difference from STYLAGE® Hydro: Hydro is a reinforced hyaluronic acid gel (14 mg/g) with mannitol, indicated at the dermo-epidermal junction and in the superficial dermis. HydroMax is a cross-linked gel (12.5 mg/g) with sorbitol, indicated in the mid to deep dermis. They are not interchangeable.
- IPN-Like technology (InterPenetrated Networks): VIVACY's patented cross-linking technology. It preserves the partial independence of the interpenetrated hyaluronic acid networks while increasing the density of chemical nodes. The manufacturer associates it with the optimisation of the gel's rheology — in particular the viscosity, to ensure injectability — and with the cohesivity and monophasic character of the gel.
- Cross-linker: BDDE. Hyaluronic acid of non-animal origin.
- Bi-SOFT® syringe: patented bi-material injection system (polycarbonate and thermoplastic elastomer with a soft-touch surface), with oversized plunger and finger flanges and an optimised centre of gravity. It is a property of the syringe, not of the gel: it aims to reduce the perceived injection force and improve control of the deposit.
- Sterile, non-pyrogenic gel, of physiological pH and osmolarity, packaged in a pre-filled syringe and sterilised by autoclave (moist heat). The needles are sterilised by irradiation or ethylene oxide.
Differences between the variants of the STYLAGE® range
The range is graded by hyaluronic acid concentration and degree of cross-linking, which determines the consistency of the gel and, with it, the injection plane and the indication. The concentrations are taken from the manufacturer's instructions for use and are expressed per gram of gel (q.s. to 1 g).
| S — 16 mg/g | Superficial to mid dermis. Cutaneous depressions of the face; lip definition by injection into the mucosa. 0.8 ml syringe |
|---|---|
| M — 20 mg/g | Mid to deep dermis. Cutaneous depressions; lip definition and/or volume augmentation; restoration of volume on the dorsum of the hand by the subcutaneous route |
| L — 24 mg/g | Deep dermis. Cutaneous depressions of the face. Not indicated for superficial wrinkles or for thin skin, lips or areas with an exposed vascular network |
| XL — 26 mg/g | Deep dermis or subcutaneous plane. Restoration or augmentation of facial volumes. It is the highest concentration in the range |
| XXL — 21 mg/g | Deep dermis or subcutaneous plane. High-viscosity volumising; the only one in the range whose pack includes a cannula |
| Special Lips — 18.5 mg/g | Labial mucosa. Redefinition and/or augmentation of lip volume |
| HydroMax — 12.5 mg/g | Mid to deep dermis. Skin hydration and elasticity. The only one in the range formulated with sorbitol instead of mannitol |
The concentration of XXL is lower than that of XL: the range is not a linear ascending scale. XL and XXL share a volumising indication and injection plane, and differ in the rheological behaviour of the gel — the manufacturer positions XXL as a high-viscosity volumiser.
Indications and treatment areas
Injectable hyaluronic acid gel indicated to improve skin hydration and elasticity by injection into the mid to deep dermis.
- Face
- Neck
- Décolletage
- Dorsum of the hand
It is not a volumetric filler or a wrinkle-correction product: its purpose according to the instructions for use is the rehydration and reinforcement of skin elasticity.
Technique and treatment protocol
- Injection plane: mid to deep dermis.
- Recommended techniques: nappage, papules or a combination of both.
- The practitioner must select the needle of appropriate length according to the area treated, the type of correction sought and the technique chosen, from those supplied.
- Only the needles supplied with the product should be used: the combination of both devices has been validated by the manufacturer. Screw the needle firmly onto the Luer-Lock cone.
- Do not inject too deeply: this would reduce the efficacy of the revitalisation. An injection that is too superficial may cause discolouration or small indurations.
- The amount to be injected depends on the area treated and on the level of dehydration of the skin.
- It is recommended not to inject more than 20 ml of cross-linked hyaluronic acid per person per year (all ranges combined).
- Sessions: depending on the patient's skin and the depth of injection, one to three sessions are required for optimal treatment. Regular touch-up sessions maintain the result.
- After injection: do not apply cold and massage the treated area thoroughly to optimise the uniformity of the correction.
- Advise the patient to massage the area thoroughly in the days following the injection, especially if the micropapule technique has been used.
Technical data
| Manufacturer | Laboratoires VIVACY, Archamps Technopole, 74160 Archamps (France) |
|---|---|
| Active substance | Cross-linked hyaluronic acid 12.5 mg/g |
| Anaesthetic | Not contained |
| Cross-linker | BDDE |
| Active excipient | Sorbitol (moisturising agent) — contains no mannitol |
| Technology | IPN-Like (cross-linking) · Bi-SOFT® syringe |
| pH | 7.2 (phosphate buffer) |
| Presentation | 1 pre-filled syringe of 1.0 ml |
| Needles | 2 sterile single-use needles (gauge not specified in the instructions for use) |
| Application plane | Mid to deep dermis |
| Classification | Medical device with CE marking in accordance with Directive 93/42/EEC; notified body 0344. According to the instructions for use, STYLAGE® HydroMax obtained CE marking in 2009 |
| Traceability | VIVACY remote authentication system with RFID technology |
| Use | Qualified healthcare professionals only |
Storage and pack contents
- Storage: in its original packaging between 2 °C and 25 °C, protected from freezing and from light. Failure to comply with the storage conditions may affect the performance of the product.
- If it has been kept in a refrigerator, allow the product to reach room temperature before injection.
- Do not use after the expiry date shown on the packaging and on the syringe. Do not use if the packaging is damaged.
- Single-use product. Do not reuse or resterilise, even if the implant has not been injected. Inject immediately after opening.
- The pack contains: 1 pre-filled syringe of 1.0 ml, 2 sterile single-use needles, instructions for use and labels with the batch number — one for the patient and one for the medical record.
Contraindications and warnings
Must not be used:
- in combination with a peel, a laser treatment or dermabrasion (the practitioner decides the waiting period required after these treatments)
- in patients with a tendency to develop hypertrophic scars
- in patients with known hypersensitivity to any of the components
- in pregnant or breastfeeding women, or in children
- in areas or in the vicinity of areas with inflammatory or infectious skin problems (acne, herpes, etc.)
- in patients with fructose intolerance (contraindication specific to HydroMax because of its sorbitol content)
Precautions for use: it is strongly recommended to obtain the patient's informed consent. In patients with a history of herpes, the punctures may trigger a new outbreak. In patients with declared autoimmune disease or a history thereof, the practitioner must decide on a case-by-case basis, propose a prior double test and not inject if the disease is progressive. Patients with a history of streptococcal disease (recurrent tonsillitis, rheumatic fever) must undergo a prior double test; in the case of rheumatic fever with cardiac involvement, injection is not recommended. In the case of a haemostatic disorder or anticoagulant therapy, the risk of haematoma is increased. The intake of aspirin, NSAIDs, antiplatelet agents, anticoagulants or vitamin C should be avoided in the week before injection.
Vascular risk: do not inject into blood vessels. Accidental intravascular injection may cause vascular occlusion with rare but serious complications — visual disturbances, blindness, necrosis of the skin and/or of the underlying tissues — depending on the area injected. Do not inject into nerves: accidental nerve injury may cause transient paraesthesia.
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 instructions for use of Laboratoires VIVACY (OPDC342 v4) and on the manufacturer's technical documentation. This data sheet does not replace the instructions for use accompanying the product.
