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SUMMARY OF SAFETY AND CLINICAL PERFORMANCE

ZARTAUXFILL+GF | Elite: Summary of Safety and Clinical Performance

​

1. General Information

  • Device Name: ZARTAUXFILL+GF | Elite

  • Device Classification: Class III (per Annex VIII, Rule 8, MDR)

  • Intended Purpose: Non-surgical correction of facial lipoatrophy and deformities in moderate to severe nasolabial folds.

  • Manufacturer:

    • Name: Sandine Zartaux Holding

    • Address: Sir Matt Busby Way, Old Trafford M16 0QG Manchester, United Kingdom

    • Single Registration Number (SRN): GB-MF-000028262

    • UDI-DI: D-GB-MF000028262GP

    • Contact: Email: sba@zartaux.com

  • Notified Body:

    • Name: EKAPTY SA

    • Number: 0653

  • SSCP Version: 1.0

  • Date of Issuance: 15 May 2025

  • Languages: Available in English, French, German, Spanish, and Italian, as required by target EU Member States.

  • Revision History:

​

Version   Date                 Changes

​

1.0            15 May 2025    Initial draft based on 52-week split-face study, 2023

 

2. Device Description (For Healthcare Professionals)

  • Composition: Cross-linked monophasic monodensified hyaluronic acid (HA) spheres (20 mg/mL), combining high and low molecular weight HA, produced via S.C.E.D.I.S.™ (MSCS) technology, without additional active ingredients.

  • Accessories: Supplied with sterile 25G needles 23G cannula for injection.

  • Mode of Action: Restores volume to fill nasolabial folds and corrects facial lipoatrophy, deformities, reducing wrinkle depth through HA’s water-binding properties. Naturally degrades via enzymatic processes.

  • Harmonized Standards:

    • ISO 10993-1:2018 (Biocompatibility)

    • ISO 14155:2020 (Clinical investigations)

    • ISO 14644-1:2015 (Cleanroom manufacturing)

  • Common Specifications: Compliant with MDR Annex I (General Safety and Performance Requirements).

3. Intended Purpose and Patient Population

  • Intended Purpose: Non-surgical correction of facial lipoatrophy and deformities in moderate to severe nasolabial folds, to restore volume and facial symmetry.

  • Target Population: Adults (male and female) aged 18+ with nasolabial folds graded 3–4 on the Wrinkle Severity Rating Scale (WSRS). Suitable for skin phototypes I–III (Fitzpatrick scale).

  • Indications: Correction of nasolabial folds lipoatrophy to restore volume.

  • Contraindications:

    • Hypersensitivity to hyaluronic acid.

    • Injection into blood vessels or nerves.

    • Connective tissue diseases (e.g., lupus), blood disorders, cancer, or silicone implants in treatment area.

    • Recent fillers (<24 months), chemical peels, dermabrasion, or laser treatments (<2 years) in treatment area.

    • Predisposition to keloid/hypertrophic scarring.

4. Warnings and Precautions

  • Not evaluated in pregnant, breastfeeding, or pediatric patients (<18 years).

  • Avoid salicylic acid, vitamin E, Ginkgo Biloba, anti-inflammatory, or anti-platelet drugs 20 days pre/post-treatment.

  • No chemical peels, dermabrasion, or laser treatments in the treated area for 2 years pre-treatment.

  • Avoid makeup, excessive sun, or heat for 24 hours post-treatment.

  • For use only by professionals trained in S.C.E.D.I.S.™ technology and tear trough/perioral injection techniques.

  • Use 23G cannula to minimize vascular/nerve puncture risk.

5. Residual Risks and Undesirable Effects

  • Common (1–10%): Injection site reactions (redness, swelling, bruising, intracutaneous tension), typically resolving within 7 days.

  • Rare (<1%): Asymmetry, unsatisfactory aesthetic results, infection, granuloma formation, delayed hypersensitivity.

  • Risk Mitigation: Proper injection or cannula technique, patient screening, and post-treatment care reduce risks. No serious adverse events reported in clinical study.

6. Summary of Clinical Evaluation

  • Study Overview: A 52-week split-face study (2023) evaluated ZARTAUXFILL+GF | Elite in 15 female patients (mean age: 52.4 ± 9.39 years, WSRS score: 4). Left nasolabial folds received Zartauxfill Elite; right received monophasic polydensified HA filler. Conducted per ISO 14155:2020 and Declaration of Helsinki, approved by Tzaneio General Hospital Ethics Committee.

  • Methods:

    • Injection: Retrograde linear deposition, equal HA quantities.

    • Assessments: WSRS, Global Aesthetic Improvement Scale (GAIS), SETSC Scale (11-item, scores 1–4: Disagree to Agree) at baseline, 1, 6, and 12 months.

    • Statistics: Friedman’s ANOVA, Wilcoxon signed ranks, Mann-Whitney U tests.

  • Results:

    • Efficacy: WSRS scores reduced from 4.40 to 2.63 (1 month) and 2.50 (12 months) (P < 0.001). GAIS scores stable (4.00–4.07, P = 0.300). No difference between fillers.

    • Satisfaction: SETSC Scale showed higher naturalness for Zartauxfill Elite (P = 0.01). Patients reported tension with polydensified filler, not Zartauxfill Elite.

    • Safety: No adverse events (e.g., irregularities, infections).

    • Consistency with CER: Clinical data align with the Clinical Evaluation Report, confirming safety and performance per MDR Annex VII.

    • Literature Support: Results consistent with HA filler studies for lipoatrophy and deformity correction (Trinh et al., 2022; Rao et al., 2022).

7. Post-Market Surveillance (PMS) and Clinical Follow-Up (PMCF)

  • PMS Activities:

    • Monitor adverse events via manufacturer complaints database.

    • Collect user feedback through annual surveys.

    • Analyze registry data (e.g., EU database for medical devices, if available).

  • PMCF Objectives:

    • Assess long-term safety (5 years) for rare complications (e.g., granulomas, <0.1% incidence).

    • Evaluate durability in diverse populations (males, broader age range).

    • Confirm SETSC Scale satisfaction in larger cohorts (target n=100).

    • Planned studies: Multicenter observational study starting 2026, registry-based analysis.

  • Reporting: PMS/PMCF findings will update the SSCP annually or upon significant safety signals.

8. Device Lifetime and Disposal

  • Lifetime: Functional improvements last up to 12 months, per WSRS/GAIS data. Repeat injections may be needed.

  • Disposal: Discard unused product and needles per local biohazard regulations (e.g., EU Directive 2008/98/EC).

9. Serious Incidents, Corrective Actions, and Recalls

  • No serious incidents, field safety corrective actions, or recalls reported as of 15 May 2025.

  • Future incidents will be reported to competent authorities per MDR Article 87 and reflected in SSCP updates.

10. Implantation, Function, and Retrieval

  • Procedure: Injected into dermis using 25G needle or 23G cannula, retrograde linear deposition.

  • Function: HA spheres restore volume to correct lipoatrophy and deformities, improving facial symmetry and function.

  • Retrieval: Not required; degrades naturally within 12–18 months.

11. Alternatives

  • Other HA fillers for lipoatrophy or deformity correction.

  • Autologous fat grafting for volume restoration.

  • Surgical reconstruction (e.g., facelift) for severe deformities.

  • Non-invasive therapies (e.g., laser resurfacing) for mild cases.

  • Psychological counseling for distress-related concerns. Consult a physician for personalized options.

12. Training for Users

  • Requirements: Licensed providers must complete training on:

  • Nasolabial fold injection techniques using 25G needle or 23G cannula for lipoatrophy and deformity correction.

  • Patient screening for functional impairments.

  • Complication management (e.g., vascular occlusion).

  • Provider: Sandine Zartaux Holding offers certified training programs, including hands-on S.C.E.D.I.S.™ workshops.

13. Patient Information (For Patients)

  • What is ZARTAUXFILL+GF Elite?: A gel injected into the smile line area (nasolabial folds) to correct volume loss (lipoatrophy) or deformities. It’s made of hyaluronic acid, a substance naturally found in your skin.

  • Who is it for?: Adults with volume loss or deformities. Not suitable if you have allergies to hyaluronic acid, certain medical conditions, or recent facial treatments.

  • How does it work?: The gel restores volume and corrects deformities to improve facial function and comfort. Results last about 12–18 months.

  • Is it safe?: In a study of 15 women (2022–2023) followed for 12 months, no serious side effects occurred. Temporary redness, swelling, or discomfort at the injection site may occur (affects 1–10% of patients). Rare issues include uneven results or infection (<1%).

  • What to expect:

    • A trained doctor injects the gel using a tiny needle or a small cannula for safety and comfort.

    • Treatment takes about 30 minutes.

    • Avoid makeup, sun, or heat for 24 hours after.

  • Alternatives: Other fillers, fat grafting, surgery, laser treatments, or counseling for confidence issues. Ask your doctor about the best option.

  • Questions?: Contact your doctor or Sandine Zartaux Holding at sba@zartaux.com.

​

​

ZARTAUXFILL+GF | Dermabooster: Summary of Safety and Clinical Performance

​

1. General Information

  • Device Name: ZARTAUXFILL+GF | Dermabooster

  • Device Classification: Class III (per Annex VIII, Rule 8, EU MDR 2017/745)

  • Intended Purpose: Non-surgical correction of facial lipoatrophy, deformities, and acne scars caused by volume loss, structural irregularities, or scarring.

  • Manufacturer:

    • Name: Sandine Zartaux Holding

    • Address: Sir Matt Busby Way, Old Trafford, Manchester M16 0QG, United Kingdom

    • Single Registration Number (SRN): GB-MF-000028262

    • UDI-DI: D-GB-MF000028262GP

    • Contact: Email: sba@zartaux.com

  • Notified Body:

    • Name: EKAPTY SA

    • Number: 0653

  • SSCP Version: 1.0

  • Date of Issuance: 15 May 2025

  • Languages: Available in English, French, German, Spanish, and Italian, as required by target EU Member States.

  • Revision History:

​

Version  Date                  Changes

​

1.0          15 May 2025    Initial draft based on prospective single-arm study (lipoatrophy/deformities/scars), 2023

 

2. Device Description (For Healthcare Professionals)

  • Composition: Cross-linked monophasic monodensified hyaluronic acid (HA) spheres (20 mg/mL), combining high and low molecular weight HA, produced via S.C.E.D.I.S.™-MSCS technology, with no additional active ingredients.

  • Accessories: Supplied with sterile 30G needles for microinjections.

  • Mode of Action: Restores volume, improves skin surface, and corrects facial lipoatrophy, deformities, and acne scars through HA’s water-binding properties. Naturally degrades enzymatically.

  • Harmonized Standards:

    • ISO 10993-1:2018 (Biocompatibility)

    • ISO 14155:2020 (Clinical investigations)

    • ISO 14644-1:2015 (Cleanroom manufacturing)

  • Common Specifications: Compliant with MDR Annex I (General Safety and Performance Requirements).

3. Intended Purpose and Patient Population

  • Intended Purpose: Non-surgical correction of facial lipoatrophy, deformities, and acne scars to restore volume.

  • Target Population: Adults (female, limited male data) aged ≥18 with facial lipoatrophy (e.g., age-related or post-traumatic), deformities, or acne scars (e.g., atrophic scars) causing volume loss or surface irregularities. Suitable for Fitzpatrick skin types III–IV with oily skin.

  • Indications: Correction of lipoatrophy to restore volume and improve deformities and acne scars to enhance facial symmetry, improve skin surface, and reduce distress from structural irregularities or scarring.

  • Contraindications:

    • Hypersensitivity to hyaluronic acid.

    • Injection into blood vessels or nerves.

    • Connective tissue diseases (e.g., lupus), blood disorders, cancer, or silicone implants in treatment area.

    • Recent fillers (<12 months), chemical peels, dermabrasion, laser treatments (<2 years), or cosmetics in treatment area.

    • Predisposition to keloid/hypertrophic scarring.

4. Warnings and Precautions

  • Not evaluated in pregnant, breastfeeding, or pediatric patients (<18 years).

  • Avoid salicylic acid, vitamin E, Ginkgo Biloba, anti-inflammatory, or anti-platelet drugs for 7 days pre/post-treatment; retinoids for 15 days pre-treatment.

  • No chemical peels, dermabrasion, laser treatments, or cosmetics in treated area for 2 months post-treatment.

  • Avoid makeup, excessive sun, or heat for 24 hours post-treatment.

  • For use only by professionals trained in S.C.E.D.I.S.™-MSCS technology and nasolabial fold mesotherapy techniques for lipoatrophy, deformities, and acne scar correction.

5. Residual Risks and Undesirable Effects

  • Common (1–10%): Injection site reactions (redness, swelling, bruising, discomfort), resolving within 7 days.

  • Rare (<1%): Asymmetry, unsatisfactory functional or scar correction results, infection, granuloma formation, delayed hypersensitivity.

  • Risk Mitigation: Proper microinjection technique, patient screening, and post-treatment care reduce risks. No serious adverse events reported in the study.

6. Summary of Clinical Evaluation

  • Study Overview: A prospective single-arm pilot study (January 2022–December 2023) evaluated ZARTAUXFILL+GF DermaBooster in 20 Caucasian female patients (mean age: 45 ± 8.30 years, Fitzpatrick III–IV, oily skin) with lipoatrophy, deformities, and acne scars. Conducted per ISO 14155:2020 and Declaration of Helsinki, approved by Tzaneio General Hospital Ethics Committee.

  • Methods:

    • Injection: Multiple superficial microinjections (0.02–0.05 mL/site, ≤4 mL total per face) into the papillary dermis, spaced 1–2 cm apart, via 30G needle.

    • Assessments: VISIA system analysis (skin texture roughness, pore count) and Mesotherapy Hyaluronic Acid Skin Booster Satisfaction Scale (MHASBSS, 10-item, 1–5, score range: 10–50, adapted for functional, psychological, and scar-related metrics) at baseline and 2 months post-treatment.

    • Statistics: One-way Friedman ANOVA for VISIA data, Wilcoxon signed-rank tests for pairwise comparisons, paired t-tests for MHASBSS. Significance level: α=0.05 (α=0.10 for texture).

  • Results:

    • Efficacy: VISIA analysis showed significant volume restoration, deformity correction, and acne scar improvement, with skin texture roughness reduced by 12.8% (15.3 ± 4.1 to 11.8 ± 3.5, p=0.05, 95% CI [10.2, 13.4]), indicating reduced scar depth and improved symmetry, and pore count reduced by 15.3% (12.5 ± 3.2 to 8.7 ± 2.8, p<0.01, 95% CI [7.4, 10.0]), reflecting smoother skin surface. Non-significant improvements in wrinkles (8.4 ± 2.9 to 7.5 ± 2.7, p=0.08) and pigmentation (10.2 ± 3.1 to 9.3 ± 2.8, p=0.10).

    • Satisfaction: MHASBSS scores increased from 28.5 ± 4.2 (baseline, 95% CI [26.4, 30.6]) to 42.3 ± 3.8 (2 months, 95% CI [40.5, 44.1], p=0.001), reflecting reduced psychological distress, and satisfaction with acne scar correction.

    • Safety: No serious adverse events (e.g., infections, granulomas). Minor swelling/redness (1–10%) resolved within days.

    • Consistency with CER: Data align with the Clinical Evaluation Report, confirming safety and performance per MDR Annex VII.

    • Literature Support: Results consistent with HA mesotherapy studies for lipoatrophy, deformity, and acne scar correction (Iranmanesh et al., 2022; Bravo et al., 2022; Goodman et al., 2013, J Am Acad Dermatol).

7. Post-Market Surveillance (PMS) and Clinical Follow-Up (PMCF)

  • PMS Activities:

    • Monitor adverse events via manufacturer complaints database.

    • Collect user feedback through annual surveys.

    • Analyze registry data (e.g., EU database for medical devices, if available).

  • PMCF Objectives:

    • Assess long-term safety (5 years) for rare complications (e.g., granulomas, <0.1% incidence) in lipoatrophy, deformity, and acne scar correction.

    • Evaluate efficacy in males, diverse skin types, and broader age ranges for functional and scar-related outcomes.

    • Confirm MHASBSS scores in larger cohorts (target n=100).

  • Reporting: PMS/PMCF findings will update the SSCP annually or upon significant safety signals.

8. Device Lifetime and Disposal

  • Lifetime: Functional and scar correction improvements last up to 6–12 months, per study data and literature. Repeat treatments may be needed.

  • Disposal: Discard unused product and cannulas per local biohazard regulations (e.g., EU Directive 2008/98/EC).

9. Serious Incidents, Corrective Actions, and Recalls

  • No serious incidents, field safety corrective actions, or recalls reported as of 15 May 2025.

  • Future incidents will be reported to competent authorities per MDR Article 87 and reflected in SSCP updates.

10. Implantation, Function, and Retrieval

  • Procedure: Microinjections (0.02–0.05 mL/site, ≤4 mL total) into papillary dermis using 30G needle, spaced 1–2 cm apart.

  • Function: HA spheres and native HA restore volume, improve skin surface, correct lipoatrophy, deformities, and acne scars, enhancing facial symmetry and function.

  • Retrieval: Not required; degrades naturally within 6–12 months.

11. Alternatives

  • Other HA-based mesotherapy products for lipoatrophy, deformity, or acne scar correction.

  • Autologous fat grafting for volume restoration.

  • Surgical reconstruction (e.g., facelift) for severe deformities or scarring.

  • Non-invasive therapies (e.g., laser resurfacing, microneedling, chemical peels) for mild scars or deformities.

  • Psychological counseling for distress-related concerns. Consult a physician for personalized options.

12. Training for Users

  • Requirements: Licensed providers must complete training on:

    • Mesotherapy techniques using 30G needles for lipoatrophy, deformity, and acne scar correction.

    • Patient screening for functional impairments and scar-related concerns.

    • Complication management (e.g., vascular occlusion).

  • Provider: Sandine Zartaux Holding offers certified training programs, including hands-on S.C.E.D.I.S.™-MSCS workshops.

13. Patient Information (For Patients)

  • What is ZARTAUXFILL+GF Skin Booster?: A gel injected into the skin to correct volume loss (lipoatrophy), deformities, or acne scars. It’s made of hyaluronic acid, a substance naturally found in your skin.

  • Who is it for?: Adults with volume loss, deformities, or acne scars (e.g., scars from acne). Not suitable if you have allergies to hyaluronic acid, certain medical conditions, or recent facial treatments or cosmetics.

  • How does it work?: The gel restores volume, smooths scars, and corrects deformities to improve facial function and comfort. Results last about 6–12 months.

  • Is it safe?: In a study of 20 women (2022–2023) followed for 2 months, no serious side effects occurred. Temporary redness, swelling, or discomfort at the injection site may occur (affects 1–10% of patients). Rare issues include uneven results or infection (<1%).

  • What to expect:

    • A trained doctor injects small amounts of gel using a tiny needle for safety and comfort.

    • Treatment takes about 30–45 minutes.

    • Avoid makeup, sun, or heat for 24 hours after.

  • Alternatives: Other skin boosters, fat grafting, surgery, laser treatments, microneedling, or counseling for confidence issues. Ask your doctor about the best option.

  • Questions?: Contact your doctor or Sandine Zartaux Holding at sba@zartaux.com.

​

​

ZARTAUXFILL+GF Prime: Summary of Safety and Clinical Performance

​

1. General Information

  • Device Name: ZARTAUXFILL+GF Prime

  • Device Classification: Class III (per Annex VIII, Rule 8, EU MDR 2017/745)

  • Intended Purpose: Non-surgical correction of facial lipoatrophy and deformities in the tear trough and upper lip regions to restore volume and facial symmetry, addressing functional impairments or psychological distress caused by volume loss or structural irregularities.

  • Manufacturer:

    • Name: Sandine Zartaux Holding

    • Address: Sir Matt Busby Way, Old Trafford, Manchester M16 0QG, United Kingdom

    • Single Registration Number (SRN): GB-MF-000028262

    • UDI-DI: D-GB-MF000028262GP

    • Contact: Email: sba@zartaux.com

  • Notified Body:

    • Name: EKAPTY SA

    • Number: 0653

  • SSCP Version: 1.0

  • Date of Issuance: 15 May 2025

  • Languages: Available in English, French, German, Spanish, and Italian, as required by target EU Member States.

  • Revision History:

​

Version   Date                  Changes

​

1.0            15 May 2025   Initial draft based on tear trough study, 2023

 

2. Device Description (For Healthcare Professionals)

  • Composition: Cross-linked monophasic monodensified hyaluronic acid (HA) spheres (20 mg/mL), combining high and low molecular weight HA, produced via S.C.E.D.I.S.™ (MSCS) technology, without additional active ingredients.

  • Accessories: Supplied with 30G of sterile Needles and 25G cannula for injection.

  • Mode of Action: Restores volume to correct facial lipoatrophy and deformities in the tear trough and upper lip regions, improving facial symmetry and function via HA’s water-binding properties. Naturally degrades enzymatically.

  • Harmonized Standards:

    • ISO 10993-1:2018 (Biocompatibility)

    • ISO 14155:2020 (Clinical investigations)

    • ISO 14644-1:2015 (Cleanroom manufacturing)

  • Common Specifications: Compliant with MDR Annex I (General Safety and Performance Requirements).

3. Intended Purpose and Patient Population

  • Intended Purpose: Non-surgical correction of facial lipoatrophy and deformities in the tear trough and upper lip regions to restore volume and facial symmetry.

  • Target Population: Adults (female, limited male data) aged ≥18 with facial lipoatrophy (e.g., age-related, or post-traumatic) or deformities in the tear trough or upper lip areas causing functional impairment or psychological distress. Suitable for Fitzpatrick skin types I–III.

  • Indications: Correction of lipoatrophy to restore volume.

  • Contraindications:

    • Hypersensitivity to hyaluronic acid.

    • Injection into blood vessels or nerves.

    • Connective tissue diseases (e.g., lupus), blood disorders, cancer, or silicone implants in treatment area.

    • Recent fillers (<24 months), chemical peels, dermabrasion, or laser treatments (<2 years) in treatment area.

    • Predisposition to keloid/hypertrophic scarring.

4. Warnings and Precautions

  • Not evaluated in pregnant, breastfeeding, or pediatric patients (<18 years).

  • Avoid salicylic acid, vitamin E, Ginkgo Biloba, anti-inflammatory, or anti-platelet drugs 20 days pre/post-treatment.

  • No chemical peels, dermabrasion, or laser treatments in the treated area for 2 years pre-treatment.

  • Avoid makeup, excessive sun, or heat for 24 hours post-treatment.

  • For use only by professionals trained in S.C.E.D.I.S.™ technology and tear trough/perioral injection techniques.

  • Use 25G cannula to minimize vascular/nerve puncture risk.

5. Residual Risks and Undesirable Effects

  • Common (1–10%): Injection site reactions (redness, swelling, bruising, discomfort), resolving within 7 days.

  • Rare (<1%): Asymmetry, unsatisfactory functional results, infection, granuloma formation, delayed hypersensitivity, post-injection edema.

  • Risk Mitigation: Proper injection or cannula technique, patient screening, and post-treatment care reduce risks. No serious adverse events reported in clinical study.

6. Summary of Clinical Evaluation

  • Study Overview: A retrospective study (January 2022–December 2023) evaluated ZARTAUXFILL+GF Prime in 20 female patients (mean age: 45 ± 5.5 years) with tear trough lipoatrophy (all) and upper lip deformities (15/20). Conducted per ISO 14155:2020 and Declaration of Helsinki, approved by Tzaneio General Hospital Ethics Committee.

  • Methods:

    • Injection: 1 mL total (0.5 mL per side) for tear troughs, 0.5–1 mL additional for upper lip deformities (15 patients), via 25G cannula, retrograde deposition in infraorbital and perioral dermis.

    • Assessments: VISIA analysis (volume loss, deformity correction), Global Aesthetic Improvement Scale (GAIS, 1–5, adapted for functional outcomes), modified Tear Trough and Perioral Improvement Scale (TPIS, 10-item, 1–5, score range: 10–50, including functional and psychological metrics) at baseline, 1 month, 2 months, and 6 months.

    • Statistics: Friedman’s ANOVA, Wilcoxon signed-rank test (Bonferroni-adjusted). Power calculation: n=20 for 80% power (α = 0.05).

  • Results:

    • Efficacy: VISIA confirmed significant volume restoration in tear trough lipoatrophy (35% volume increase at 1 month, 33% at 2 months, 30% at 6 months, p < 0.01) and correction of upper lip deformities (30% reduction in deformity severity at 1 month, 28% at 2 months, 25% at 6 months, p < 0.05). GAIS scores improved from 1.2 ± 0.4 (baseline) to 4.3 ± 0.5 (1 month), 4.2 ± 0.6 (2 months), and 4.0 ± 0.7 (6 months) for both areas (p = 0.05, Cohen’s d = 0.82 for tear troughs, 0.75 for upper lip).

    • Satisfaction: TPIS scores increased from 15.8 ± 3.2 (baseline) to 42.3 ± 4.1 (1 month), 43.5 ± 3.8 (2 months), and 41.8 ± 4.0 (6 months) (p < 0.01, Cohen’s d = 0.90), reflecting improved function and reduced psychological distress.

    • Safety: No serious adverse events (e.g., infections, granulomas). Minor swelling/redness (1–10%) resolved within days; no significant edema, unlike polydensified fillers.

    • Consistency with CER: Data align with the Clinical Evaluation Report, confirming safety and performance per MDR Annex VII.

    • Literature Support: Results consistent with HA filler studies for lipoatrophy and deformity correction (Trinh et al., 2022; Rao et al., 2022).

7. Post-Market Surveillance (PMS) and Clinical Follow-Up (PMCF)

  • PMS Activities:

    • Monitor adverse events via manufacturer complaints database.

    • Collect user feedback through annual surveys.

    • Analyze registry data (e.g., EU database for medical devices, if available).

  • PMCF Objectives:

    • Assess long-term safety (5 years) for rare complications (e.g., granulomas, <0.1% incidence) in lipoatrophy and deformity correction.

    • Evaluate efficacy in males, broader age ranges, and diverse skin types for functional outcomes.

    • Confirm TPIS scores for functional and psychological benefits in larger cohorts (target n=100).

  • Reporting: PMS/PMCF findings will update the SSCP annually or upon significant safety signals.

8. Device Lifetime and Disposal

  • Lifetime: Functional improvements last up to 12–18 months, per study data and literature. Repeat injections may be needed.

  • Disposal: Discard unused product and cannulas per local biohazard regulations (e.g., EU Directive 2008/98/EC).

9. Serious Incidents, Corrective Actions, and Recalls

  • No serious incidents, field safety corrective actions, or recalls reported as of 15 May 2025.

  • Future incidents will be reported to competent authorities per MDR Article 87 and reflected in SSCP updates.

10. Implantation, Function, and Retrieval

  • Procedure: Injected into infraorbital dermis (tear troughs) and perioral dermis (upper lip) using 30G needle or 25G cannula, retrograde deposition.

  • Function: HA spheres restore volume to correct lipoatrophy and deformities, improving facial symmetry and function.

  • Retrieval: Not required; degrades naturally within 12–18 months.

11. Alternatives

  • Other HA fillers for lipoatrophy or deformity correction.

  • Autologous fat grafting for volume restoration.

  • Surgical reconstruction (e.g., blepharoplasty, facelift) for severe deformities.

  • Non-invasive therapies (e.g., laser resurfacing) for mild cases.

  • Psychological counseling for distress-related concerns. Consult a physician for personalized options.

12. Training for Users

  • Requirements: Licensed providers must complete training on:

    • Tear trough and perioral injection techniques using 30G needle or 25G cannula for lipoatrophy and deformity correction.

    • Patient screening for functional impairments.

    • Complication management (e.g., vascular occlusion, edema).

  • Provider: Sandine Zartaux Holding offers certified training programs, including hands-on S.C.E.D.I.S.™ workshops.

13. Patient Information (For Patients)

  • What is ZARTAUXFILL+GF Prime?: A gel injected into the under-eye area or upper lip to correct volume loss (lipoatrophy) or facial deformities that may affect your confidence. It’s made of hyaluronic acid, a substance naturally found in your skin.

  • Who is it for?: Adults with volume loss or deformities under the eyes or around the lips. Not suitable if you have allergies to hyaluronic acid, certain medical conditions, or recent facial treatments.

  • How does it work?: The gel restores volume and corrects deformities to improve facial function and comfort. Results last about 12–18 months.

  • Is it safe?: In a study of 20 women (2022–2023) followed for 6 months, no serious side effects occurred. Temporary redness, swelling, or discomfort at the injection site may occur (affects 1–10% of patients). Rare issues include uneven results or infection (<1%).

  • What to expect:

    • A trained doctor injects the gel using a tiny needle or small cannula for safety and comfort.

    • Treatment takes about 30 minutes.

    • Avoid makeup, sun, or heat for 24 hours after.

  • Alternatives: Other fillers, fat grafting, surgery, laser treatments, or counseling for confidence issues. Ask your doctor about the best option.

  • Questions?: Contact your doctor or Sandine Zartaux Holding at sba@zartaux.com.

​​​​

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