FILLMED® ART FILLER® Universal – 2 × 1.2ml (Authorised FILLMED Reseller)

FILLMED® ART FILLER® Universal – 2 × 1.2ml

FILLMED® ART FILLER® Universal is a premium cross-linked Hyaluronic Acid (HA) dermal filler with 0.3% lidocaine, developed for the correction of medium-to-deep facial lines and wrinkles, facial folds and selected areas of volume loss.

Manufactured by FILLMED in Europe, ART FILLER® Universal is designed as a highly versatile injectable within the ART FILLER® range, allowing appropriately qualified medical practitioners to address multiple facial indications with a single formulation.

Formulated with 25mg/ml cross-linked Hyaluronic Acid, ART FILLER® Universal combines effective filling capacity with a cohesive, elastic and supple gel texture. This balance allows the product to integrate naturally within the tissues while providing sufficient support for the correction of moderate-to-deeper wrinkles and folds.

ART FILLER® Universal incorporates FILLMED's proprietary Tri-Hyal® Technology, combining very long, long and free Hyaluronic Acid chains to create a gel with carefully controlled rheological properties and smooth injectability.

Within the ART FILLER® collection, Universal provides a versatile middle ground between ART FILLER® Fine Lines, which is primarily designed for superficial wrinkles, and ART FILLER® Volume, which is intended for deeper structural volumisation and facial contour restoration.

FILLMED also indicates ART FILLER® Universal for increasing lip volume and enhancing the lip outline where clinically appropriate.

The formulation contains 0.3% lidocaine hydrochloride for its local anaesthetic properties, helping to improve patient comfort during administration.

Pack Contents

Each box contains:

• 2 × 1.2ml pre-filled syringes of FILLMED® ART FILLER® Universal
• Total product volume: 2.4ml
• 4 × sterile single-use 27G ½" needles
• 25mg/ml cross-linked Hyaluronic Acid
• 0.3% lidocaine hydrochloride
• Product information leaflet
• 4 × traceability labels
• Sterile professional-use packaging

Each syringe contains 1.2ml of sterile ART FILLER® Universal gel and is intended for single use only.

The supplied traceability labels support appropriate recording of the implanted medical device within the patient's clinical records and full product traceability.

Always check the individual product packaging and FILLMED's current Instructions for Use before treatment.

Product Composition

Cross-Linked Hyaluronic Acid – 25mg/ml

ART FILLER® Universal contains 25mg/ml cross-linked Hyaluronic Acid of non-animal origin.

The Hyaluronic Acid forms a cohesive and elastic viscoelastic gel designed to provide controlled correction of medium-to-deep wrinkles and folds while supporting natural tissue integration.

Its characteristics are designed to support:

• Correction of medium-to-deep facial wrinkles
• Filling of appropriate facial folds
• Restoration of selected areas of volume loss
• Improved facial contours
• Natural tissue integration
• Smooth and controlled correction
• Lip volume enhancement where clinically appropriate
• Lip-outline enhancement
• Natural facial movement and expression

The cross-linked Hyaluronic Acid gel is biodegradable and gradually absorbed by the body over time.

Lidocaine Hydrochloride – 0.3%

ART FILLER® Universal contains 0.3% lidocaine hydrochloride.

Lidocaine is incorporated into the formulation for its local anaesthetic properties and is intended to help improve patient comfort during administration.

Tri-Hyal® Technology

ART FILLER® Universal incorporates FILLMED's proprietary Tri-Hyal® Technology.

This technology combines:

• Very long Hyaluronic Acid chains
• Long Hyaluronic Acid chains
• Free Hyaluronic Acid

By carefully controlling the ratio of these different HA components, FILLMED creates distinct rheological characteristics across the ART FILLER® collection.

ART FILLER® Universal has been specifically formulated to provide a balance between:

• Cohesivity
• Elasticity
• Suppleness
• Filling capacity
• Spreadability
• Tissue integration
• Injectability

Within the ART FILLER® collection, Universal has an intermediate cross-linking profile, providing greater corrective capacity than ART FILLER® Fine Lines while remaining more adaptable than the structurally focused ART FILLER® Volume.

This versatility makes ART FILLER® Universal suitable for a broad range of facial indications.

Medium-to-Deep Wrinkle Correction

ART FILLER® Universal is specifically designed for the correction of medium-to-deep facial wrinkles and folds.

Its cohesive and elastic characteristics provide immediate mechanical correction following administration while supporting smooth integration within facial tissues.

Treatment objectives may include:

• Filling medium facial wrinkles
• Correcting deeper facial folds
• Improving the appearance of nasolabial folds
• Improving the appearance of marionette lines
• Restoring selected areas of lost facial volume
• Improving facial contours and harmony
• Smoothing appropriate age-related facial creases
• Supporting natural-looking facial rejuvenation

Its versatile rheological profile makes Universal particularly useful where greater corrective capacity than a fine-line filler is required without necessarily requiring the higher structural properties of a dedicated volumising filler.

Key Benefits

• Premium FILLMED® Hyaluronic Acid dermal filler
• Highly versatile formulation
• Designed for medium-to-deep facial lines and wrinkles
• Suitable for correction of appropriate facial folds
• Supports replacement of selected areas of lost volume
• Contains 25mg/ml cross-linked Hyaluronic Acid
• Contains 0.3% lidocaine for improved treatment comfort
• Incorporates proprietary Tri-Hyal® Technology
• Combines very long, long and free Hyaluronic Acid
• Cohesive, elastic and supple gel texture
• Supports natural tissue integration
• Smooth and controlled injectability
• Suitable for appropriate needle or cannula administration
• Can be used for lip volume and lip-outline enhancement where clinically appropriate
• Supports natural-looking facial correction
• Supplied as 2 × 1.2ml pre-filled syringes
• Total product volume of 2.4ml
• Supplied with 4 × sterile 27G ½" needles
• Manufactured in Europe by FILLMED
• CE-marked injectable medical device
• Full product traceability
• Intended strictly for appropriately qualified medical professional use

Common Treatment Areas

ART FILLER® Universal is designed as a versatile dermal filler for the correction of medium-to-deep wrinkles, facial folds and selected areas of volume loss.

Potential treatment areas may include:

• Nasolabial folds
• Marionette lines
• Medium-to-deep facial wrinkles
• Facial folds and creases
• Cheeks where clinically appropriate
• Selected lower-face volume deficiencies
• Lips where increased volume is desired
• Lip outline / vermilion border
• Other appropriate facial areas requiring medium-to-deep correction

Treatment suitability should always be determined according to the patient's individual anatomy, tissue quality, degree of volume loss, wrinkle depth and professional clinical assessment.

For more superficial wrinkles, ART FILLER® Fine Lines may provide a more appropriate option, while ART FILLER® Volume is specifically designed for deeper volume restoration and facial contouring.

Professional Treatment Considerations

ART FILLER® Universal should only be administered by appropriately qualified medical professionals with suitable training and competence in dermal filler procedures.

Before treatment, practitioners should undertake:

• Comprehensive patient consultation
• Full medical history
• Facial and anatomical assessment
• Assessment of wrinkle or fold depth
• Evaluation of facial volume loss
• Review of previous aesthetic procedures
• Assessment of contraindications
• Discussion of realistic treatment expectations
• Explanation of potential adverse effects and complications
• Appropriate informed consent

ART FILLER® Universal is intended for injection into the middle-to-deep dermis for the correction of appropriate facial folds and wrinkles.

The product is supplied with 27G ½" sterile single-use needles and may also be administered using an appropriate cannula technique where clinically indicated.

Treatment volume, injection depth, administration technique and product placement should always follow FILLMED's current Instructions for Use, appropriate professional training and individual patient assessment.

Clinical Performance

ART FILLER® Universal has been clinically evaluated for the correction of facial wrinkles and folds.

FILLMED reports clinical performance data demonstrating sustained improvement following treatment of nasolabial folds.

In a multicentre prospective clinical study evaluating ART FILLER® Universal for nasolabial-fold correction, FILLMED reports that 100% of evaluated patients maintained a clinically significant improvement at 18 months following treatment.

Clinical-study outcomes relate to the evaluated study population and should not be interpreted as a guarantee of individual treatment results or longevity.

Results & Longevity

ART FILLER® Universal is designed to provide an immediate corrective effect following administration.

Potential treatment outcomes may include:

• Reduced appearance of medium-to-deep wrinkles
• Smoother-looking facial folds
• Improved appearance of nasolabial folds
• Improved appearance of marionette lines
• Restoration of selected areas of facial volume
• Improved facial contours
• Enhanced lip volume where clinically appropriate
• Improved lip definition
• Natural-looking facial rejuvenation

The cross-linked Hyaluronic Acid gel is biodegradable and gradually absorbed by the body over time, meaning treatment results are temporary.

Clinical data reported by FILLMED demonstrates sustained improvement in nasolabial folds for up to 18 months within the evaluated study population.

Individual longevity will vary according to factors including:

• Treatment area
• Amount of product administered
• Patient age
• Skin and tissue quality
• Metabolism
• Facial movement
• Lifestyle
• Previous aesthetic treatments
• Practitioner technique
• Individual biological response

Maintenance or repeat treatment may be considered following professional reassessment and according to individual patient requirements.

Important Information

FILLMED® ART FILLER® Universal is a CE-marked injectable medical device intended strictly for use by appropriately qualified medical professionals.

ART FILLER® Universal is a sterile, colourless, transparent, non-pyrogenic, saline viscoelastic cross-linked Hyaluronic Acid gel of non-animal origin containing 0.3% lidocaine hydrochloride.

Professional knowledge of facial anatomy, vascular anatomy, dermal filler injection techniques, aseptic practice and the prevention, recognition and management of complications is essential.

Treatment should only proceed following comprehensive patient consultation, review of medical history, assessment of contraindications, examination of the proposed treatment area, review of previous injectable treatments and appropriate informed consent.

Temporary treatment-site reactions associated with injectable dermal fillers may include redness, swelling, bruising, tenderness, mild discomfort, localised sensitivity and temporary firmness.

More significant complications are possible with any injectable dermal filler procedure. Practitioners must possess appropriate training and competence in the prevention, recognition and management of complications, including vascular complications.

Practitioners should always consult the current FILLMED Instructions for Use for complete indications, contraindications, precautions, warnings, administration guidance and potential adverse events before treatment.

Each syringe and supplied needle is intended for single use only.

For full product traceability, the supplied traceability labels should be recorded and provided in accordance with FILLMED's Instructions for Use and applicable professional requirements.

Do not use if the sterile packaging is damaged or compromised, the syringe or product appears damaged, the product has passed its expiry date, or product integrity or authenticity is in doubt.

For medical professional use only.