BIOABSORBABLE
BIOLOGICALLY-DERIVED
What is P4HB?
Hint: It’s not animal, cadaver or even synthetic
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.
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
A fully-absorbable, biologically-derived polymer
BIOABSORBABLE
BIOLOGICALLY-DERIVED
1
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.
4,5,6
How P4HB works
Early repair response
After GalaFLEX™ Scaffold is implanted, there is a gradual transfer of the load from the scaffold to the ingrown tissue.
Long-term support
3,4,8
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.
4,5,6
How P4HB works
Early repair response
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
3,4,8
Designed to minimize risk of infection and encourage natural healing response.
4,5,8-11
Monofilament design
Designed to minimize risk of infection and encourage natural healing response.
Monofilament design
4,5,8-11
Monofilament materials have been shown to have, on average, 60% less surface area than multifilament materials, potentially leading to an improved healing response.
4,5,8-11
4,5,8-11
The monofilament scaffold was designed with an open pore knit pattern to reduce risk of infection.
4,5,8-11
4,5,8-11
GalaFLEX™ Scaffold maintains greater than 70% of its strength at 12 weeks in vivo.⁴
70%
GalaFLEX™ Scaffold maintains greater than 70% of its strength at 12 weeks in vivo.⁴
Tissue repaired with P4HB has been shown to be 2-4x stronger than native tissue.²'⁴'⁷
GalaFLEX™ Scaffold maintains greater than 70% of its strength at 12 weeks in vivo.⁴
70%
Tissue repaired with P4HB has been shown to be 2-4x stronger than native tissue.²'⁴'⁷
2-4x
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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.
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 Biomed Mater Res. 2002;63(6):765-71.
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.