What is Surgical Scaffold? | Monofilament Mesh for Reconstructive Surgery

Home The Surgical Scaffold Collection What is a Galatea Scaffold?

Elevate. Support. Repair. Reinforce.

Galatea surgical scaffolds are bioresorbable, monofilament mesh, constructed of poly-4-hydroxybutyrate (P4HB™ Biopolymer) — an advanced, biologically produced polymer.

Watch the Galatea Scaffold Collection Overview here.

Indications for Use

Galatea scaffolds are indicated for use as a bioresorbable scaffold 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. Galatea scaffold is also indicated for the repair of fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

Galatea Scaffold Monofilament Construction – Photo 20x

Galatea 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 and biological fermentation process, standard in pharmaceutical production, designed for biocompatibility and a minimal inflammatory response ^[33,36]

Monofilament

Knitted with an open-pore design to minimize risk of infection and encourage a healing response ^{[7,8,15,18,36]}

Strong

Provides a lattice for new tissue ingrowth and regeneration resulting in tissue 3-5x stronger than native tissue ^[8,36]

Bioresorbable

Naturally broken down to CO₂ and H₂O primarily through the process of hydrolysis, with full bioresorption by 18-24 months ^[7]

3-Dimensional

The first and only formed design that fits and uplifts the body's natural shape, providing easier placement and reduced procedure time

See how Galatea surgical scaffolds work.

Find out why you should use Galatea scaffolds to support your next surgical procedure.

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+ Show References

1. Data on file, ASAPS. 2013.
2. Martin, DP and Williams, SF (2003) “Medical applications of poly-4-hydroxybutytrate: a strong flexible absorbable biomaterial” Bio Eng Journal 16:97-105.
3. Amid, PK (1997) “Classification of biomaterials and their related complications in abdominal wall hernia surgery” Hernia 1:15-21.
4. Amid, PK (1997) “Biomaterials for tension-free hernioplasties and principles of their applications” Minerva Chir 50(9):821-6.
5. Goldstein, HS (1999) “Selecting the right mesh” Hernia 3:23-26.
6. Amid, PK (1994) “Biomaterials for abdominal wall hernia surgery and principles of their applications” Lang Arch Chir 379:168-71.
7. Martin, DP et al. (2013) “Characterization of poly-4-hydroxybutyrate mesh for hernia repair applications” Journal of Surgical Research 184:766-73.
8. Wolloscheck, T (2004) “Inguinal hernia: Measurement of the biomechanics of the lower abdominal wall and the inguinal canal” Hernia 8:233-41.
9. Quan, M. et al. “Defining Pseudoptosis (Bottoming Out) 3 Years After Short-Scar Medial Pedicle Breast Reduction.” Aesth Plast Surg (2011) 35:357–364.
10. Data on file. Galatea Surgical Post Market Physician Preference Study. 2014.
11. Lamb, PJ (1983) “Comparative evaluation of synthetic meshes used for abdominal wall replacement” Surgery 93:643-48.
12. SERI Surgical Scaffold Website. Retrieved July 2015 from http://www.seri.com/product
13. TIGR Resorbable Matrix Marketing Materials. Retrieved September 2013, from http://www.novusscientific.com
14. Deeken CR (2011) “Histologic and Biomechanical Evaluation of Crosslinked and Non-Crosslinked Biologic Meshes in a Porcine Model of Ventral Incisional Hernia Repair.” J Am Coll Surg 212:880-88
15. 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.
16. Data limited to single site experience. Galatea Surgical. 2014.
17. K. E. Mulier, A. H. Nguyen, J. P. Delaney, S. Marquez. “Comparison of Permacol™ and Strattice™ for the repair of abdominal wall defects.” Springer. 19 October 2010.
18. Halaweish I, Harth K, Broome AM, Voskerician G, Jacobs MR, Rosen M. “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.” J Surg Infect (Larchmt). 2010; Oct1(5): 449-54.
19. Badylak, S.F. “Load transfer: mechanism of Phasix™ fully resorbable mesh degradation and tissue integration for a durable repair. A scientific, evidence-based theory of progressive load transfer.” White paper. Bard Davol, 2015.
20. Galatea scaffold® Mesh: FDA 510(k) clearance K140533, May 21, 2014.
21. TephaFLEX® Absorbable Suture: FDA 510(k) clearance K052225, February 8, 2007.
22. Müller H-M, Seebach, D. “Poly(hydroxyalkanoates): A fifth class of physiologically important organic biopolymers?” Angew Chem Int Ed Engl. 1993, 32:477-502.
23. Guo K, Martin DP. “Poly-4-hydroxybutyrate (P4HB) in biomedical applications and tissue engineering. In Chu C-C, ed. Biodegradable Polymers. Volume 2: New Biomaterial Advancement and Challenges.” Hauppauge, NY: Nova Science Publishers; in press.
24. S. Todros, P. G. Pavan, A. N. Natali. “Synthetic surgical meshes used in abdominal wall surgery: Part I materials and structural conformation.” Society for Biomaterials. 9 June 2015.
25. Nelson T, Kaufman E, Kline J, Sokoloff L. “The extraneural distribution of γ-hydroxybutyrate.” J Neurochem. 1981; 37:1345-1348.
26. Sendelbeck SL, Girdis CL. “Disposition of a 14C-labeled bioerodible polyorthoester and its hydrolysis products, 4-hydroxybutyrate and cis, trans-1,4-bis(hydroxymethyl)cyclohexane, in rats.” Drug Metab Dispos. 1985; 13(3):291-295.
27. Minami E. Koh IH. Ferreira JC. et al. The composition and behavior of capsules around smooth and textured breast implants in pigs. Plast Reconstr Sug. Sep 15 2006;118(4):874-884.
28. Tamboto H, Vickery K Deva AK. Subdinical (biofilm) infection causes capsular contracture in a porcine model following augmentation mammaplasty. PRS. 2010;126(3):835-842.
29. Anita Jacombs JA. Honghua Hu, Pedro Miguel Valente. William L. F. Wessels, Anand K. Deva and Karen Vickery. Prevention of Biofilm-lnduced Capsular Contracture With Antibiotic-Impregnated Mesh in a Porcine Model. Aesthetic Surgery Journal. 2012:32(7): 886-891.
30. Jacombs A, Allan J, Hu H. et al. The use of antibiotic impregnated mesh reduces the formation of biofilm induced capsular contracture in the porcine model. Aesthetic Surg J. 2012:Sept 32(7):886-891.
31. Maxwell GP. Gabriel A Efficacy of acellular dermal matrices in revisionary aesthetic breast surgery. a 6 year experience. Aesthetic Surg J. Mar 2013:33(3):389·399.
32. Pozner JN. White JB, Newman Ml. Use of porcine acellular dermal matrix in revisionary cosmetic breast augmentation. Aesthetic Surg J. Jul 2013:33(5):681-690
33. Data on file at Tepha, Inc.
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35. Jr HT, BH G. HR M, FR N. MW. L. S. Use of dermal matrix to prevent capsular contracture in aesthetic breast surgery. Plast Reconstr Surg. 2012:130 (5 Suppl 2126S-36S).
36. Data on File at Tepha. Similar studies in humans have not been performed.
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39. Klinge, U., et al. “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.” Journal of biomedical materials research 63.6 (2002): 765-771.
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Elevate. Support. Repair. Reinforce.

Watch the Galatea Scaffold Collection Overview here.

Indications for Use

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

Biologically Derived

Monofilament

Strong

Bioresorbable

3-Dimensional

See how Galatea surgical scaffolds work.

Find out why you should use Galatea scaffolds to support your next surgical procedure.

Contact Us Today!

Indications for Use

Important Safety Considerations