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PACK MIX ELLANSÉ (ELLANSÉ S + ELLANSÉ M) AQTIS Medical

PACK MIX ELLANSÉ (ELLANSÉ S + ELLANSÉ M) AQTIS Medical

ELLANSÉ

Aesthetic medicine – dermal fillers
  • CE Marked Class III medical device under EU Medical Devices Directive 93/42/EEC for subdermal implantation in the face for lasting correction of wrinkles and facial ageing signs
  • Manufactured under an ISO 13485–compliant quality management system for medical devices
  • Conforms to relevant EN ISO 10993 biocompatibility standards for medical devices in contact with tissue and body fluids
  • Conforms to EN ISO 11137 / EN ISO 11135 and related standards for sterilisation and sterility assurance of medical devices
  • Subject to Summary of Safety and Clinical Performance (SSCP) with supporting clinical evaluation demonstrating safety and performance over up to 24 months, depending on variant
Polycaprolactone-based collagen-stimulating dermal filler mix pack (Ellans\u00e9 S + Ellans\u00e9 M)

Description

PACK MIX ELLANSÉ (ELLANSÉ S + ELLANSÉ M) by AQTIS Medical / Sinclair is a professional-use mix pack of two polycaprolactone (PCL)–based collagen-stimulating dermal fillers. The pack contains one box of Ellansé S (2 × 1 ml prefilled syringes) and one box of Ellansé M (2 × 1 ml prefilled syringes) for subdermal implantation in the face to restore lost volume, correct wrinkles and facial ageing signs, and contour facial features. Ellansé products combine immediate volumising from a carboxymethylcellulose (CMC) gel carrier with long-lasting neocollagenesis induced by smooth PCL microspheres, providing visible, natural-looking results that typically last around 1 year for Ellansé S and up to 2 years for Ellansé M. The fillers are CE-marked Class III medical devices, non-animal, bioresorbable and designed exclusively for use by trained healthcare professionals in medical aesthetic practice.

Bnefits

  • Immediate correction of facial wrinkles, folds and volume loss with visible results after a single treatment session
  • Long-lasting performance: Ellansé S typically around 12 months and Ellansé M up to approximately 24 months, depending on patient factors
  • Biostimulatory effect via polycaprolactone microspheres that stimulate the body’s own type I collagen production for sustained improvement in skin density, firmness and elasticity
  • Restores and enhances facial contours (cheeks, chin, jawline, temples, nose bridge) with natural-looking volume
  • Fully bioresorbable and biocompatible implant composed of smooth PCL microspheres in a CMC gel carrier
  • Soft, homogeneous gel for predictable placement and good tissue integration using standard dermal filler techniques
  • Designed to maintain full correction for the intended duration before gradual resorption
  • CE-marked Class III medical device manufactured under stringent quality and safety standards
  • Non-animal, non-bacterial synthetic composition with an established safety profile in aesthetic indications
  • Pack mix (S + M) allows the practitioner to tailor duration of effect and treatment strategy for different facial areas

Indications

  • Subdermal implantation in the face for the lasting correction of wrinkles and facial ageing signs or conditions in adult patients
  • Restoration of facial volume loss due to ageing (midface, cheeks, chin, jawline, temples)
  • Correction of moderate to severe facial wrinkles and folds such as nasolabial folds and marionette lines
  • Treatment of fine lines on the lips and cheeks
  • Filling more pronounced wrinkles on the cheeks, forehead or chin
  • Facial contouring and enhancement of structures such as cheekbones, chin and jawline
  • Non-surgical profile refinement and correction of depressions at the bridge of the nose (within approved facial indications)
  • Treatment of age-related facial laxity by volumetric support in appropriate anatomical planes (mid to deep dermis or subcutaneous fat) by trained practitioners

Composition

  • Polycaprolactone (PCL) microspheres – approximately 30% of the product by volume; totally smooth, spherical particles (approximately 25–50 μm) that are biocompatible, bioresorbable and fully degradable to CO₂ and H₂O
  • Carboxymethylcellulose (CMC) gel carrier – approximately 70% of the product; synthetic, fully resorbable gel providing the immediate filling effect over 2–3 months
  • Physiological buffered saline and excipients in the CMC-based gel carrier (no animal-derived components)
  • No added lidocaine (local anaesthetic is typically not included in standard Ellansé S and M presentations)

Formulation

  • Injectable, sterile, apyrogenic, non-pyrogenic gel implant for single use
  • 70% carboxymethylcellulose (CMC) aqueous gel carrier providing immediate volume and facilitating injection
  • 30% synthetic polycaprolactone (PCL) microspheres embedded in the CMC gel, acting as a long-lasting collagen stimulator
  • Non-animal, non-bacterial, fully bioresorbable, biocompatible soft tissue filler
  • Supplied as prefilled 1 ml syringes with Luer-lock connection for use with 27G 3/4" needles or cannulas, according to the instructions for use

Packaging

  • Mix pack containing: 1 × Ellansé S (2 × 1 ml prefilled syringes) and 1 × Ellansé M (2 × 1 ml prefilled syringes)
  • Each Ellansé S box: 2 × 1 ml sterile prefilled syringes and 4 × 27G 3/4" sterile single-use needles, plus package insert
  • Each Ellansé M box: 2 × 1 ml sterile prefilled syringes and 4 × 27G 3/4" sterile single-use needles, plus package insert
  • Ready-to-use, sterile blister and secondary carton packaging, labelled for professional medical use only
  • CE-marked Class III medical device labelling with product reference, lot number and expiry date

Usage

  • For strict medical use only; Ellansé S and Ellansé M must only be injected by qualified and appropriately trained healthcare professionals experienced in soft tissue augmentation and familiar with Ellansé instructions for use.
  • Before treatment, obtain full medical history, assess indications and contraindications, discuss expectations, and obtain informed consent.
  • Cleanse and disinfect the treatment area using appropriate antiseptic techniques under aseptic conditions.
  • Attach the supplied 27G 3/4" needle or a suitable sterile cannula to the prefilled syringe according to the manufacturer’s instructions, ensuring secure Luer-lock connection and removal of air bubbles.
  • Inject slowly into the mid to deep dermis or subcutaneous/hypodermal layer of the face depending on the indication and anatomical location, using appropriate linear threading, fanning or bolus techniques while aspirating according to local practice to reduce risk of intravascular injection.
  • Avoid intravascular injection and high-risk vascular zones; do not overcorrect and distribute product evenly to achieve smooth, natural results.
  • Gently mould or massage the treated area if required to optimise contour and integration, following the instructions for use and clinical training guidance.
  • Provide post-treatment advice, including avoiding make-up for a period (often ~12–24 hours), avoiding excessive pressure, extreme temperatures, saunas, swimming pools and strenuous exercise until initial swelling and redness have subsided.
  • Schedule follow-up review to assess outcomes and manage any adverse effects or need for additional treatment.
  • Use each syringe for a single patient only and dispose of all sharps and used devices in accordance with local regulations and infection control standards.

Contraindications

  • Known hypersensitivity or allergy to any component of the product (e.g., polycaprolactone, carboxymethylcellulose or excipients)
  • Pregnant or breast-feeding women, or patients actively trying to conceive or undergoing assisted reproduction, as the product is not indicated in these groups
  • Patients under 18 years of age
  • History of hypertrophic or keloid scarring or a tendency to form keloids in the proposed treatment area
  • Active skin disease, inflammation or infection (e.g., acne, psoriasis, dermatitis, cold sores/herpes labialis) at or near the intended injection site
  • Systemic infection, fever or significant acute illness at the time of treatment
  • Uncontrolled systemic diseases such as poorly controlled diabetes, significant autoimmune or connective tissue disorders, immunosuppression (medical or drug-related), active malignancy or recent chemotherapy/radiotherapy, unless carefully evaluated and cleared by the treating physician
  • Known coagulation disorders or current use of anticoagulant or antiplatelet medication that significantly increases bleeding risk, unless carefully assessed and managed by the treating clinician
  • Previous permanent fillers or implants (e.g., silicone) or certain surgical materials in the intended treatment area where interaction with Ellansé could pose a risk
  • Recent isotretinoin (Roaccutane) therapy (typically within the last 6 months), according to expert guidelines
  • Any condition or circumstance that, in the opinion of the treating practitioner, could increase the risk of complications or interfere with healing, including unrealistic expectations or inability to comply with aftercare instructions

Adverse Effects

  • Common injection-related reactions: transient pain or tenderness, erythema (redness), swelling/oedema, warmth, pruritus and local discomfort at the injection site
  • Bruising or ecchymosis at injection sites, which may occasionally be extensive and take up to two weeks or more to resolve
  • Transient lumps, irregularities or firmness due to product placement or local swelling; usually resolve but may require massage or clinical review
  • Nodules or granuloma-like reactions (delayed lumps) which may appear weeks to months after treatment; may be associated with inflammation or triggered by intercurrent illness or immune activation and require specialist management
  • Infection at the injection site, presenting with warmth, redness, swelling and pain days after treatment; may require antibiotics and medical intervention
  • Reactivation of herpes simplex (cold sores), particularly when treating perioral regions
  • Hypersensitivity or inflammatory reactions, including prolonged redness, swelling or induration
  • Vascular occlusion due to inadvertent intravascular injection or external compression, characterised by severe pain, skin blanching or livedo, and poor capillary refill; can lead to tissue ischaemia, necrosis and scarring if not promptly recognised and managed
  • Extremely rare but serious complications reported with dermal fillers in general, such as visual disturbance or blindness due to embolisation to retinal vessels, and cerebrovascular events including stroke when filler enters or compresses arterial circulation in high-risk areas
  • Other rare events described with soft tissue fillers such as prolonged oedema, delayed inflammatory reactions, or late-onset immune-mediated responses

Storage Conditions

  • Store Ellansé S and Ellansé M in their original packaging in a clean, dry, secure environment.
  • Recommended storage temperature: generally between 15 °C and 25 °C (or 2–25 °C depending on specific local IFU), protected from direct sunlight.
  • Do not freeze; avoid excessive heat or temperature fluctuations.
  • Keep out of the reach and sight of children and unauthorised persons.
  • Do not use after the expiry date indicated on the packaging and do not use if the blister or syringe appears damaged or compromised.
  • Store and transport in accordance with local regulations for sterile Class III medical devices.

Duration

Typical visible effect is immediate and maintained for approximately 1 year with Ellans\u00e9 S and up to approximately 2 years with Ellans\u00e9 M; actual duration depends on patient factors, treatment area, volume injected and practitioner technique.

Onset

Immediate volumising and wrinkle-correcting effect directly after injection from the CMC gel carrier, with progressive improvement over several months as PCL microspheres stimulate neocollagenesis and remodel facial contours.

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