What is P4HB™?

What is P4HB?

Poly-4-hydroxybutyrate (P4HB) belongs to a large group of naturally occurring biopolymers, known as polyhydroxyalkanoates (PHAs). PHAs exist in nature as energy reserves in microorganisms that can be stored and utilized when needed.

P4HB degrades gradually and predictably by hydrolysis, resulting in a minimal inflammatory response with less acidic byproducts or remodeling challenges, as compared to other soft tissue support devices.19

  • P4HB degrades into 4HB, a natural metabolite endogenously found in the human brain, heart, kidney, liver, lung, muscle, and brown adipose tissue.
  • The body rapidly catabolizes 4HB via the Krebs cycle and eliminates it as CO2 and H2O.

The Galatea Difference

These unique properties of P4HB, particularly in comparison to other polymers commonly used in resorbable medical devices, such as polyglycolide (PGA) and polylactide (PLA), make it possible to produce a high strength biomaterial without sacrificing elasticity.

  • 29 regulatory clearances for medical products made from P4HB, as of 2020
  • Over 60 published clinical and scientific papers on P4HB
  • More than 3+ million patients have P4HB devices implanted1

Internal Soft Tissue Support Beyond the Procedure

The Galatea scaffold collection is designed specifically for strength retention throughout the critical wound healing period 1,19 and provides a lattice for new tissue ingrowth.16 As the scaffold bioabsorbs, the new ingrown tissue provides the strength to repair site.19 By 52 weeks, the ingrown tissue is approximately 2.4 mm thick and provides the majority of repair strength.2,23

Before Implantation

Galatea Scaffold is a macroporous, monofilament, bioabsorbable scaffold.2

After
Implantation

(Human Tissue Specimens)

Tissue rapidly grows into the pores of the Galatea scaffold, and forms a well-vascularized tissue plane.2

The newly formed tissue is pliable and provides strength and support to the elevated tissue.16

Watch the Galatea Scaffold Collection Overview

Biologically Derived

Produced by a safe biological fermentation process, standard in pharmaceutical production. [12, 17]

Monofilament

Designed to minimize risk of infection and encourage a natural healing response. [3, 15]

Strong

Provides a lattice for new tissue ingrowth and regeneration resulting in tissue 3-4x stronger than native tissue. [9, 16, 19]

Bioabsorbable

Naturally broken down to CO2 and H2O and bioabsorption is essentially complete by 18-24 months.
[1,12]

3-Dimensional

The first and only formed absorbable scaffold designed to fit and uplift the body's natural shape, providing easier placement and reduced procedure time. [1]

Predictible Performance

Promotes healing and stability due to predictable performance. [1]

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Indications for Use

GalaFLEX, GalaFLEX 3D and GalaFLEX 3DR scaffolds are indicated for use as bioresorbable scaffolds for soft tissue support and to repair, elevate, and reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome. This includes reinforcement of soft tissue in plastic and reconstructive surgery, and general soft tissue reconstruction. These products, referred to as Galatea scaffolds, are also indicated for the repair of fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

Important Safety Information

Possible complications following implantation of Galatea scaffolds include infection, seroma, pain, scaffold migration, wound dehiscence, hemorrhage, adhesions, hematoma, inflammation, extrusion and recurrence of the soft tissue defect. The safety and product use of Galatea scaffolds for patients with hypersensitivities to the antibiotics kanamycin sulfate and tetracycline hydrochloride is unknown. Galatea scaffolds have not been studied for use in breast reconstructive surgeries. The safety and effectiveness of Galatea scaffolds in neural tissue and in cardiovascular tissue has not been established. The safety and effectiveness of Galatea scaffolds in pediatric use has not been established. Consult the specific Galatea scaffold Instructions for Use for complete prescribing information, including its indications for use, warnings and precautions.

References

  1. 1. Data on file at Tepha.
  2. *2. Preclinical data on file at Tepha; results may not correlate to clinical performance in humans.
  3. 3. Engelsman, A. F., van der Mei, H. C., Ploeg, R. J., & Busscher, H. J. “The Phenomenon of Infection with Abdominal Wall Reconstruction.” Biomaterials, vol. 28 no. 14, 2018, pp. 2314-2327.
  4. 9. Deeken, Corey R., and Brent D. Matthews. “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 Surgery. 2013.
  5. 12. “Chapter 7: Poly-4-hydroxybutyrate (P4HB) in Biomedical Applications and Tissue Engineering.” Biodegradable Polymers Volume 2, by Kai Guo and David Martin, 2015 Nova Science Publishers, Inc, 2015.
  6. 15. 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 Reserve, vol. 63, no. 6, 2002, pp. 765-71.
  7. 16. Martin, D P, et al. “Characterization of Poly-4-Hydroxybutyrate Mesh for Hernia Repair Applications.” Journal of Surgical Research, vol. 184, no. 2, 2013, pp. 766–773.
  8. 17. Martin, David P., and Simon F. Williams. “Medical Applications of Poly-4-Hydroxybutyrate: a Strong Flexible Absorbable Biomaterial.” Biochemical Engineering Journal, vol. 16, no. 2, 2003, pp. 97-105.
  9. 19. Scott, J. R., Deeken, C. R., Martindale, R. G., Rosen, M. J. “Evaluation of a Fully Absorbable Poly-4-Hydroxybutyrate/Absorbable Barrier Composite Mesh in a Porcine Model of Ventral Hernia Repair.” Surgical Endoscopy, vol. 30, no. 9, 2016, pp. 3691-3701.
  10. 23. Williams, Simon F., Martin, David P., Moses, Arikha C. “The History of GalaFLEX P4HB Scaffold.” Aesthetic Surgery Journal, 2016, pp. S33–S42.
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