Ellansé S (2 x 1ml)

ELLANSÉ

Dermal fillers

Polycaprolactone-based collagen-stimulating injectable dermal filler

CE Marked Class III medical device under Directive 93/42/EEC (MDD), Rule 8
Manufactured under an ISO 13485 Compliant quality management system
Conforms to relevant EN ISO 10993 biocompatibility standards for medical devices
Complies with applicable EN/ISO standards for sterility, packaging and risk management as outlined in the Ellansé Summary of Safety and Clinical Performance (SSCP)

CE Marked Class III medical device under Directive 93/42/EEC (MDD), Rule 8
Manufactured under an ISO 13485 Compliant quality management system
Conforms to relevant EN ISO 10993 biocompatibility standards for medical devices
Complies with applicable EN/ISO standards for sterility, packaging and risk management as outlined in the Ellansé Summary of Safety and Clinical Performance (SSCP)

Polycaprolactone-based collagen-stimulating injectable dermal filler

Description

Ellansé S is a sterile, single-use, bioresorbable, non-permanent dermal filler based on synthetic polycaprolactone (PCL) microspheres suspended in a carboxymethylcellulose (CMC) gel carrier. It is indicated for subdermal implantation in the face for the lasting correction of wrinkles, folds and age-related facial volume loss. Ellansé S provides immediate volumisation from its CMC gel and longer-term results through controlled collagen stimulation around the PCL microspheres, with effects typically lasting around 12–18 months before fully resorbing.

Bnefits

Immediate visible correction of wrinkles and facial folds
Long-lasting results through stimulation of the body’s own collagen
Improves skin firmness, elasticity and overall skin quality
Restores and enhances facial volume and contours
Bioresorbable and non-permanent implant
Dual action: instant volumisation plus biostimulation
Cost-effective due to longer duration compared with many HA fillers (fewer maintenance sessions)
Latex-free and non-pyrogenic formulation

Indications

Subdermal implantation in the face for lasting correction of wrinkles and facial aging signs
Moderate to severe facial wrinkles and folds (e.g. nasolabial folds, marionette lines)
Age-related facial volume loss and contour deficiencies
Mid-face volumisation and lifting
Jawline, chin and cheek contouring (in appropriately selected patients)
Treatment of certain age-related volume deficits where a collagen-stimulating filler is appropriate

Composition

Polycaprolactone (PCL) microspheres (approximately 30% of the gel by volume)
Carboxymethylcellulose (CMC) gel carrier (approximately 70% of the gel by volume)
Phosphate-buffered saline (PBS)
Glycerin
Water for injection
Latex-free, non-pyrogenic, synthetic polymer-based implant

Formulation

Sterile, single-use, bioresorbable dermal filler
Non-pyrogenic, latex-free, synthetic PCL microspheres suspended in an aqueous CMC gel
Polycaprolactone microspheres of controlled size distribution in a viscoelastic carrier gel
Supplied ready-to-use in prefilled 1 ml syringes for injection

Packaging

Box containing 2 prefilled 1 ml syringes of Ellansé S
4 sterile 27G 3/4" needles
Sterile foil pouch for each preloaded syringe
Package insert with instructions for use and safety information
Traceability labels with batch/lot number, manufacture date and expiry date

Usage

For professional use only: Ellansé S must only be injected by trained healthcare professionals experienced in soft-tissue augmentation and familiar with the product’s instructions for use.
Indicated for subdermal implantation in the face; typically injected into the mid to deep dermis or just sub-dermal plane, depending on area and technique.
Perform full medical history, suitability assessment and informed consent prior to treatment.
Clean and disinfect the treatment area thoroughly; apply topical or local anaesthesia if required, in line with local protocols.
Assemble the prefilled 1 ml syringe with the supplied 27G 3/4" needle, ensuring sterility is maintained.
Inject slowly using appropriate technique (e.g. linear threading, fanning or depot) while avoiding over-correction; massage gently if required to achieve even distribution.
Do not inject into the lips or tear trough (under-eye) region, or into blood vessels; avoid areas with active skin disease or infection.
After treatment, provide patients with aftercare advice, including avoiding makeup for several hours, extreme heat or cold, saunas and vigorous exercise until initial swelling resolves.
Schedule follow-up as needed to review outcome and monitor for any adverse events.
Always refer to and follow the full official Instructions for Use (IFU) from the manufacturer for detailed directions, contraindications, warnings and precautions.

Contraindications

Known hypersensitivity or allergy to any component of the product (e.g. polycaprolactone, carboxymethylcellulose or excipients)
Pregnancy or breastfeeding, or actively trying to conceive/undergoing IVF
Patients under 18 years of age
Active or recurrent skin conditions at or near the injection site (e.g. active acne, psoriasis, dermatitis, active herpes/cold sores)
Active local or systemic infection (including dental, ENT, chest or sinus infections)
History of severe allergies, anaphylaxis or multiple severe drug allergies (based on practitioner assessment)
Autoimmune diseases, immunosuppression or significant uncontrolled systemic illness (e.g. uncontrolled diabetes, certain connective tissue disorders) where the practitioner considers risk unacceptable
Tendency to keloid or hypertrophic scarring
Concurrent use of medications significantly affecting coagulation (e.g. warfarin, high-dose antiplatelets) without appropriate risk assessment
Presence of permanent implants or permanent fillers in the intended treatment area
Recent facial surgery or recent dermal filler injections in the same area where interaction or distortion of results may occur

Adverse Effects

Expected transient injection-site reactions such as redness (erythema), swelling (oedema), tenderness or pain, and bruising
Temporary lumps, nodules or unevenness at or near the injection site
Itching, firmness or mild induration in the treated area
Delayed-onset swelling or inflammatory reactions, sometimes associated with intercurrent illness or inflammation
Infection at the injection site, presenting with increasing redness, warmth, pain or swelling
Exacerbation of herpes simplex (cold sores) when treating perioral areas in predisposed patients
Rare but serious events such as vascular occlusion (compromised blood flow potentially leading to tissue necrosis and scarring)
Extremely rare but documented risks associated with dermal fillers in general, including visual disturbance or blindness and stroke when product is inadvertently injected into or compresses critical vessels
Any unexpected or persistent adverse effect requires prompt evaluation by the treating practitioner and management in line with current clinical guidance

Storage Conditions

Store in a controlled, sterile environment at 15–25°C.
Keep in original packaging until use to maintain sterility and protect from light.
Do not refrigerate or freeze; avoid exposure to freezing temperatures, excessive heat, direct sunlight and UV.
Do not use if packaging is damaged, compromised, or if the product is past its expiry date.

Duration

Approx. 12\u201318 months for Ellans\u00e9 S, depending on indication, injection technique, treatment area, patient age, skin condition, metabolism and lifestyle factors.

Onset

Immediate correction and volumisation from the CMC carrier gel, with progressive collagen stimulation over subsequent weeks; full biostimulatory effect generally develops over several months.