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The information contained in this website is intended for U.S. Health Care Professionals. Patients, please refer to your physician for more information.
Galatea Surgical
  • The Surgical Scaffold Collection
    • What is a Galatea Scaffold?
    • How Galatea Scaffolds work
    • Why use a Galatea Scaffold
    • GalaFLEX® Scaffold
    • GalaSHAPE® 3D Scaffold
    • GalaFORM® 3D Scaffold
    • Available Sizes
  • The Galatea Difference
    • What is P4HB?
    • History of P4HB
  • Surgeon Education
  • Resources
    • Publications
    • Instructions for Use (IFU)
    • Downloads
    • Patents
    • FAQs
  • About Us
    • In the News
    • Careers
  • Contact Us
    • The Galatea Surgical Team
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  • The Surgical Scaffold Collection
    • What is a Galatea Scaffold?
    • How Galatea Scaffolds work
    • Why use a Galatea Scaffold
    • GalaFLEX® Scaffold
    • GalaSHAPE® 3D Scaffold
    • GalaFORM® 3D Scaffold
    • Available Sizes
  • The Galatea Difference
    • What is P4HB?
    • History of P4HB
  • Surgeon Education
  • Resources
    • Publications
    • Instructions for Use (IFU)
    • Downloads
    • Patents
    • FAQs
  • About Us
    • In the News
    • Careers
  • Contact Us
    • The Galatea Surgical Team
Home Resources

Resources

Publications

Review publications (unabridged) discussing the P4HB polymer. These publications do not constitute endorsement for use in any specific procedure.

Instructions for Use

View and download Galatea scaffold Instructions for Use.

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Downloads

View and download Galatea scaffold Instructions for Use, brochures and other helpful resources.

Galatea Surgical History Icon

FAQs

Find the answers to some of the most common questions we hear from physicians about Galatea scaffold including P4HB™ material, utilizing Soft Tissue Reinforcement, clinical benefits and more.

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Patents

Review patents for Galatea Surgical scaffolds.

Have Questions About Our Surgical Scaffolds?

Connect with a Galatea Surgical representative near you for more information.

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Indications for Use

Galatea scaffold is 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. 

Important Safety Considerations

Possible complications following implantation of Galatea scaffold 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 scaffold 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 scaffold in neural tissue and in cardiovascular tissue has not been established. The safety and effectiveness of Galatea scaffold in pediatric use has not been established. Consult the Galatea scaffold Instructions for Use for complete prescribing information; including its indications for use, warnings and precautions.

The information contained in this website is intended for U.S. Health Care Professionals. Patients, please refer to your physician for more information.

Galatea Surgical
  • The Surgical Scaffold Collection
  • The Galatea Difference
  • Surgeon Education
  • Resources
  • About Us
  • Contact Us

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1. Data on file, ASAPS. 2013.
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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.
34. CR Deeken, BJ Eliason, MD Pichert, SA Grant. “Differentiation of biologic scaffold materials through physicomechanical, thermal, and enzymatic degradation techniques.” Annals of Surgery: March 2012 - Volume 255 - Issue 3 - p 595–604.
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.
37. Engelsman, Anton F., et al. “The phenomenon of infection with abdominal wall reconstruction. Biomaterials 28.14 (2007): 2314-2327.
38. Engelsman, A. F., et al. “Morphological aspects of surgical meshes as a risk factor for bacterial colonization.” British Journal of Surgery 95.8 (2008): 1051-1059.
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.
40. An, Yuehuei H., and Richard J. Friedman. “Concise review of mechanisms of bacterial adhesion to biomaterial surfaces.” Journal of Biomedical Materials Research Part A 43.3 (1998): 338-348.

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