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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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2,3,4

A fully-absorbable, biologically-derived polymer 

¿Qué es el P4HB?

Pista: No es de origen animal, cadavérico ni sintético.

Un polímero de origen biológico totalmente absorbible.

DE ORIGEN BIOLÓGICO

BIOABSORBIBLE

GalaFLEX™ Scaffold es un monofilamento de poros abiertos compuesta de poli-4-hidroxibutirato (P4HB), un polímero de origen biológico totalmente absorbible, producido a partir del monómero 4HB, un metabolito humano que se encuentra de forma natural en el cerebro, el corazón, el hígado, los riñones y los músculos.

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GalaFLEX™ Scaffold se degrada de manera gradual y predecible entre los 18 y 24 meses, y se elimina del cuerpo en forma de agua y dióxido de carbono a través de vías fisiológicas naturales.

​

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

La absorción de P4HB inicia de forma natural una transición temprana de los macrófagos de un fenotipo proinflamatorio a un fenotipo pro-remodelador. También conocidos como macrófagos de "reparación", estos macrófagos pro-remodeladores ayudan a regenerar el tejido nativo.⁴'⁵'⁶

Cómo funciona el P4HB
Respuesta temprana de reparación

Galaflex_Vetor_02_.png
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Soporte a largo plazo ²'⁴'⁷

Después de la implantación de GalaFLEX™ Scaffold, se produce una transferencia gradual de la carga del scaffold al tejido regenerado.²'⁴​

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

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

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Long-term support

2,4,7

Diseño monofilamento

Diseñado para minimizar el riesgo de infección y fomentar una respuesta de curación natural.

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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 mantiene más del 70 % de su resistencia a las 12 semanas in vivo.⁴

Se ha demostrado que el tejido reparado con P4HB es de 3-4x más fuerte que el tejido nativo.²'⁴'⁷

Contáctenos

¿Listo para elevar sus procedimientos de cirugía plástica y reconstructiva? ¡Empecemos!

  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.

Referencias
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