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

FILLMED® ART FILLER® Volume – 2 × 1.2ml

FILLMED® ART FILLER® Volume is a premium cross-linked Hyaluronic Acid (HA) dermal filler with 0.3% lidocaine, specifically developed for facial volume restoration, projection, shaping and contour enhancement.

Manufactured in Europe by FILLMED Manufacturing, ART FILLER® Volume is the most structurally focused formulation within the core ART FILLER® range and is designed for areas requiring greater support and volumisation.

Formulated with 25mg/ml cross-linked Hyaluronic Acid, ART FILLER® Volume combines a high degree of elasticity and cohesivity with FILLMED's proprietary Tri-Hyal® Technology. This creates a viscoelastic gel capable of restoring lost facial volume while allowing practitioners to shape and redefine facial contours.

FILLMED positions ART FILLER® Volume for volume restoration, with principal treatment areas including the mid-face, temples and jawline. Depending upon individual anatomy, professional assessment and the manufacturer's current Instructions for Use, the product may also be used to support cheek enhancement, chin projection and facial shaping.

Unlike ART FILLER® Fine Lines, which is designed for superficial wrinkles, and ART FILLER® Universal, which provides versatile correction of medium-to-deep wrinkles and folds, ART FILLER® Volume has the highest relative cross-linking profile within these three core ART FILLER® formulations.

This provides the structural characteristics required for deeper facial volumisation, projection and contouring.

The formulation also 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® Volume
• 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® Volume 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® Volume contains 25mg/ml cross-linked Hyaluronic Acid of non-animal origin.

The Hyaluronic Acid forms a highly cohesive and elastic viscoelastic gel specifically designed to provide structural support and replace lost facial volume.

Its characteristics are designed to support:

• Facial volume restoration
• Structural tissue support
• Facial contour enhancement
• Mid-face restoration
• Cheek projection
• Temple volume restoration
• Jawline shaping
• Chin projection where clinically appropriate
• Natural tissue integration
• Natural-looking facial rejuvenation

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

Lidocaine Hydrochloride – 0.3%

ART FILLER® Volume 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® Volume incorporates FILLMED's proprietary Tri-Hyal® Technology, developed to optimise the rheological characteristics across the ART FILLER® collection.

Tri-Hyal® Technology combines:

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

By carefully balancing these different forms of Hyaluronic Acid, FILLMED creates individual gels with specific levels of elasticity, cohesivity, cross-linking and spreadability according to their intended clinical application.

Within the core ART FILLER® range, Volume contains the highest relative proportion of very long and long HA chains and the highest relative degree of cross-linking when compared with ART FILLER® Fine Lines and ART FILLER® Universal.

This gives ART FILLER® Volume the structural characteristics required to support:

• Volume restoration
• Facial projection
• Contour enhancement
• Tissue support
• Facial shaping
• Deep structural correction

The formulation is designed to remain sufficiently modulable for appropriately trained practitioners to shape and contour the treated area while providing the support required for natural-looking volume restoration.

Facial Volume Restoration

Facial ageing involves more than the development of lines and wrinkles.

Progressive age-related changes can occur within the skin, subcutaneous fat compartments and underlying facial structures, contributing to loss of projection, reduced tissue support and changes in facial contours.

ART FILLER® Volume has been specifically developed to address facial volume loss and contour changes.

FILLMED describes the treatment principles associated with ART FILLER® Volume as:

• Lift
• Restore
• Shape
• Create

Depending upon the patient's individual anatomy and treatment objectives, ART FILLER® Volume may be used to restore lost volume, improve facial projection and enhance structural facial contours.

Its rheological characteristics make it particularly suited to areas requiring greater support than would typically be provided by a softer wrinkle-correcting filler.

Key Benefits

• Premium FILLMED® Hyaluronic Acid dermal filler
• Specifically developed for facial volume restoration
• Designed for lifting, restoring, shaping and contouring
• 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
• High relative degree of cross-linking within the core ART FILLER® range
• Provides structural tissue support
• Supports restoration of age-related facial volume loss
• Suitable for mid-face volumisation
• Supports cheek projection and contour
• Suitable for temple volume restoration
• Supports jawline definition
• May support chin projection where clinically appropriate
• Cohesive and elastic gel characteristics
• Designed for natural tissue integration
• Supports natural-looking facial rejuvenation
• 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 Manufacturing
• CE-marked injectable medical device
• Full product traceability
• Intended strictly for appropriately qualified medical professional use

Common Treatment Areas

According to FILLMED's ART FILLER® practitioner protocol, ART FILLER® Volume is indicated for facial volume restoration within areas including:

• Mid-face
• Jawline
• Temples

Depending upon individual anatomy, clinical assessment and the manufacturer's current Instructions for Use, treatment may also support:

• Cheek volume restoration
• Cheek projection
• Facial contour enhancement
• Chin projection and shaping
• Restoration of selected areas of facial volume loss

Treatment suitability should always be determined according to the patient's anatomy, degree and location of volume loss, tissue quality, facial proportions, previous aesthetic treatments and professional clinical assessment.

For medium-to-deep wrinkles and folds where substantial structural volumisation is not required, ART FILLER® Universal may provide a more appropriate option.

For superficial lines and wrinkles requiring more delicate correction, ART FILLER® Fine Lines is specifically designed for this purpose.

Professional Treatment Considerations

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

Before treatment, practitioners should undertake:

• Comprehensive patient consultation
• Full medical history
• Detailed facial and anatomical assessment
• Assessment of facial volume loss
• Evaluation of facial proportions
• Assessment of tissue quality
• Review of previous aesthetic procedures
• Assessment of contraindications
• Discussion of realistic treatment expectations
• Explanation of potential adverse effects and complications
• Appropriate informed consent

The product is supplied with 27G ½" sterile single-use needles.

FILLMED describes ART FILLER® Volume as easy to inject via needle and incorporates the product into advanced professional protocols, including its 2.4 Full Face approach and combination treatment strategies.

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

Results & Longevity

ART FILLER® Volume is designed to provide immediate volume restoration and contour enhancement following treatment.

Potential treatment outcomes may include:

• Restoration of lost facial volume
• Improved mid-face projection
• Enhanced cheek contours
• Improved temple volume
• Enhanced jawline definition
• Improved chin projection where clinically appropriate
• Improved facial proportions
• Greater structural support
• Improved facial contours
• 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.

Individual treatment longevity will vary according to factors including:

• Treatment area
• Amount of product administered
• Degree of volume loss
• 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® Volume is a CE-marked injectable medical device intended strictly for use by appropriately qualified medical professionals.

ART FILLER® Volume 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, facial ageing, dermal filler injection techniques, aseptic practice and complication prevention, recognition and management is essential.

Treatment should only proceed following:

• Comprehensive patient consultation
• Review of medical history
• Assessment of contraindications
• Detailed examination of the proposed treatment area
• Assessment of facial anatomy and volume loss
• Review of previous injectable treatments
• Discussion of realistic treatment expectations
• Explanation of possible adverse effects and complications
• Appropriate informed consent

Temporary treatment-site reactions associated with injectable dermal fillers may include:

• Redness
• Swelling
• Bruising
• Tenderness
• Mild discomfort
• Localised sensitivity
• Temporary firmness

More significant complications are possible with any injectable dermal filler procedure. Practitioners must possess appropriate training 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 administering ART FILLER® Volume.

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

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

Store ART FILLER® Volume according to FILLMED's current storage recommendations.

Do not use if:

• The sterile packaging is damaged or compromised
• The syringe or product appears damaged
• The product has passed its expiry date
• Product integrity is in doubt
• Product authenticity cannot be verified

For medical professional use only.