Galatea Surgical Scaffold Collection | P4HB Scaffold for Plastic Surgery

Home The P4HB Scaffold Collection

A biologically derived 2D scaffold for plastic and reconstructive surgery that supports, elevates, and reinforces soft tissue repairs.^[1]
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GalaFLEX 3D is the only shaped 3-dimensional scaffold for plastic and reconstructive surgery that supports, elevates, and reinforces soft tissue repairs.
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GalaFLEX 3DR scaffold is the only 3-dimensional scaffold with a reinforcing rim for plastic and reconstructive surgery that supports, elevates, and reinforces soft tissue repairs.
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GalaFLEX LITE scaffold is a lightweight, low-profile P4HB scaffold, designed for anatomical compliance, to provide predictable, restorative strength.
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Our names have changed, but our products have not.
GalaSHAPE 3D is now GalaFLEX 3D. GalaFORM 3D is now GalaFLEX 3DR.

The Galatea collection of scaffolds offer a unique combination of properties that are optimal for soft tissue reinforcement in plastic and reconstructive surgery:

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 2-4X 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 rapid integration and a predictable strength and absorption profile.^[1,2]

Explore GalaFLEX for Plastic and Reconstructive Surgery

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1. Data on file at Tepha.
*2. Preclinical data on file at Tepha; results may not correlate to clinical performance in humans.
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. Loh, Q. L., Choong, C.. “Three-dimensional scaffolds for tissue engineering applications: Role of porosity and pore size.” Tissue Engineering Part B: Reviews, vol. 19, no. 6, 2013, pp. 485-502. doi:http://dx.doi.org.portal.lib.fit.edu/10.1089/ten.teb.2012.0437
5. Alloderm Regenerative Tissue Matrix, Lifecell Electronic IFU. https://allergan-web-cdn-prod.azureedge.net/actavis/.
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7. Bengtson, B., Baxter, R. A., Clemens, M. W., & Bates, D.C50. “A 12-month Survey of Early Use and Surgeon Satisfaction With a New Highly Purified Silk Matrix: SERI SurgicalScaffold.” Plastic and Reconstructive Surgery Global Open, vol. 2, no. 7, 2014.
8. Corey R Deeken, PhD, et al. “Histologic and Biomechanical Evaluation of Crosslinked and Non-Crosslinked Biologic Meshes in a Porcine Model of Ventral Incisional Hernia Repair.” 23 Mar. 2011. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3782991/
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.
10. “Wound Closure Manual.” Ethicon, Inc. PDF file. 2005.
11. Gross, John E., et al. “An Evaluation of SERI Surgical Scaffold for Soft-Tissue Support and Repair in an Ovine Model of Two-Stage Breast Reconstruction.” Plastic and Reconstructive Surgery, vol. 134, no. 5, 2014, pp.700e-704e.
12. “Chapter 7: Poly-4-hydroxybutyrate (P4HB) in Biomedical Applications and Tissue Engineering.” Biodegradable Polymers Volume 2, by Kai Guo and David Martin, 2015 NovaScience Publishers, Inc, 2015.
13. 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, vol. 11, no. 5, 2010, pp. 449-454.
14. Hjort, H., et al. “Three-Year Results From a Preclinical Implantation Study of a Long-Term Resorbable Surgical Mesh with Time-Dependent Mechanical Characteristics.” Hernia, vol. 16, no. 2, 2012, pp. 191-197.
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.
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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.
18. Roth, J. S., et al. “Prospective Evaluation of Poly-4-Hydroxybutyrate Mesh in CDC Class L/High-Risk Ventral and Incisional Hernia Repair: 18-Month Follow-Up.” Surgical Endoscopy, vol. 32 no. 4, 2013, pp. 1929-1936.
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.
20. “Scaffold Electronic IFU.” SERI Surgical. https://www.allergan.com/.
21. “Mesh Electronic IFU.” Strattice Surgical. https://allergan-web-cdn prod.azureedge.net.
22. “Surgical Mesh Electronic IFU.” TIGR Surgical. http://novusscientific.com.
23. Williams, Simon F., Martin, David P., Moses, Arikha C. “The History of GalaFLEX P4HB Scaffold.” Aesthetic Surgery Journal, 2016, pp. S33–S42.
24. Buell, Joseph F. “Initial Experience With Biologic Polymer Scaffold (Poly-4-Hydroxybuturate) in Complex Abdominal Wall Reconstruction.” Annals of Surgery, vol. 266, no. 1, 1 July 2017, pp. 185–188.
25. Cartmill, Barry T. “How Do Absorbable Sutures Absorb? A Prospective Double-Blind Randomized Clinical Study of Tissue Reaction to Polyglactin 910 Sutures in Human Skin.” Orbit, vol. 33, no. 6, 2014, pp. 437–443.
26. Silva, Gayan S. De. “Lack of Identifiable Biologic Behavior in a Series of Porcine Mesh Explants.” Surgery, vol. 156, no. 1, 2014, pp. 183–189., doi:10.1016/j.surg.2014.03.011.
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The P4HB Scaffold Collection

Our names have changed, but our products have not.
GalaSHAPE 3D is now GalaFLEX 3D. GalaFORM 3D is now GalaFLEX 3DR.