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The information contained in this website is intended for Health Care Professionals.

If you are a patient, please consult with your physician. NOT INTENDED FOR U.S. AUDIENCES.

GalaFLEX™ Scaffold is an open pore monofilament scaffold composed of poly-4-hydroxybutyrate (P4HB), a fully-absorbable, biologically-derived polymer produced from the monomer form 4HB—a naturally occurring human metabolite found in the brain, heart, liver, kidney and muscle.

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GalaFLEX™ Scaffold degrades gradually and predictably within 18 to 24 months, and is eliminated from the body as water and carbon dioxide through natural physiologic pathways.

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1

2,3,4

A fully-absorbable, biologically-derived polymer 

什麼是 P4HB？

100%生物相容性
非動物性來源、非人體捐贈來源、非合成來源。

一種可完全吸收、源自微生物細胞庫的高分子聚合物

可吸收

源自微生物細胞庫

GalaFLEX™ Scaffold 是一種開放孔單股結構的支架，由聚-4-羥基丁酸酯 (P4HB) 所組成。P4HB 是一種可完全吸收、源自生物的高分子聚合物，由單體 4HB 製成，而 4HB 是一種天然存在於人體大腦、心臟、肝臟、腎臟與肌肉中的聚合物。

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GalaFLEX™ Scaffold 會在 18 至 24 個月內逐漸且可預測地降解，並透過自然的生理途徑，以水與二氧化碳的形式排出體外。

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1

2,3,4

A fully-absorbable, biologically-derived polymer 

GalaFLEX™ Scaffold is an open pore monofilament scaffold composed of poly-4-hydroxybutyrate (P4HB), a fully-absorbable, biologically-derived polymer produced from the monomer form 4HB—a naturally occurring human metabolite found in the brain, heart, liver, kidney and muscle.¹

​

GalaFLEX™ Scaffold degrades gradually and predictably within 18 to 24 months, and is eliminated from the body as water and carbon dioxide through natural physiologic pathways.²'³'⁴

​

BIOLOGICALLY-DERIVED

BIOABSORBABLE

P4HB 的吸收會自然引發巨噬細胞從促發炎型態轉變為促重塑型態的早期轉換。這些促重塑型態的巨噬細胞亦稱為「修復型」巨噬細胞，有助於組織再生及組織修復。⁴⁻⁶

P4HB 的作用原理
組織癒合機轉

Galaflex_Vetor_02_Chines_v2.png
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長期支撐

在植入 GalaFLEX™ Scaffold 之後，支撐力會逐漸從支架轉移到新生長入的組織。²'⁴​

2,4,7

Absorption of P4HB naturally initiates an early shift of macrophages from a pro-inflammatory phenotype to a pro-remodeling phenotype. Also known as "repair" macrophages, these pro-remodeling macrophages help to regenerate native tissue.

How P4HB works 
Early repair response

4,5,6

After GalaFLEX™ Scaffold is implanted, there is a gradual transfer of the load from the scaffold to the ingrown tissue.

2,4

Long-term support

2,4,7

單股纖維設計

降低感染風險並促進自然癒合反應。

4,5,8-11

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GalaFLEX™ Scaffold maintains greater than 70% of its strength at 12 weeks in vivo.⁴

Tissue repaired with P4HB has been shown to be 3-4x stronger than native tissue.²'⁴'⁷

GalaFLEX™ Scaffold 在體內 12 週時仍能維持超過 70% 的強度⁴

研究顯示，使用 P4HB 再生及修復的組織其強度可達原生組織的 3–4 倍²'⁴'⁷

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  1. Williams, Simon F., David P. Martin, and Arikha C. Moses. "The History of GalaFLEX P4HB Scaffold." Aesthetic Surgery Journal 36.Suppl 2 (2016): S33-S42. PMC. Web. 1 June 2017.

  2. Deeken CR, Matthews BD. Characterization of the Mechanical Strength, Resorption Properties, and Histologic Characteristics of a Fully Absorbable Material (Poly-4-hydroxybutyrate-PHASIX Mesh) in a Porcine Model of Hernia Repair: ISRN Surg 2013:2013:238067. Published 2013 May 28. doi: 10.1155/2013/238067. Native abdominal wall tissue strength adapted from Decken 2013 (69.7N +/- 13.6).

  3. GalaFLEX™ Scaffold Instructions For Use 

  4. Preclinical data on file. Results may not correlate to clinical outcomes.

  5. No scaffold is indicated for use in contaminated or infected wounds.

  6. Pineda Molina C, Giglio R, Gandhi RM, Sicari BM, Londono R, Hussey GS, et al. Comparison of the host macrophage response to synthetic and biologic surgical meshes used for ventral hernia repair. J Immunol Regen Med. (2019) 3:13–25.

  7. Scott JR, Deeken CR, Martindale RG, Rosen MJ. Evaluation of a fully absorbable poly-4-hydroxybutyrate/absorbable barrier composite mesh in a porcine model of ventral hernia repair. Surg Endosc. 2016;30(9):3691-3701. doi:10.1007/s00464-016-5057-9.

  8. Klinge U, Junge K, Spellerberg B, Piroth C, Klosterhalfen B, Schumpelick V. "Do multifilament alloplastic meshes increase the infection rate? Analysis of the polymeric surface, the bacteria adherence, and the in vivo consequences in a rat model." J

  9. Halaweish, Ihab, et al. "Novel in vitro model for assessing susceptibility of synthetic hernia repair meshes to Staphylococcus aureus infection using green fluorescent protein-labeled bacteria and modern imaging techniques." Surgical infections 11.5 (2010): 449-454.

  10. Engelsman, A. F., van der Mei, H. C., Ploeg, R. J., & Busscher, H. J. (2007). "The phenomenon of infection with abdominal wall reconstruction." Biomaterials, 28(14), 2314-2327.

  11. Deeken CR, Chen DC, Lopez-Cano M, Martin DP, Badhwar A. Fully resorbable poly-4-hydroxybutyrate (P4HB) mesh for soft tissue repair and reconstruction: A scoping review. Front Surg. 2023;10:1157661. Published 2023 Apr 12. doi:10.3389/fsurg.2023.1157661.

參考文獻
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