BiologicallyderiveddotBiologically Derived

Galatea surgical scaffold is made from P4HB™ BiopolyWoman-Scarf-Stillmer.  This biopolymer is produced through a biological fermentation process similar to methods used in the pharmaceutical industry. This proprietary process was designed for biocompatibility and a minimal inflammatory response.

The initial regulatory clearance of sutures made from P4HB by the FDA included a complete profile of standard biocompatibility testing of both the polymer and the device according to the International Standard ISO-10993 “Biological Evaluation of Medical Devices Part-1: Evaluation and Testing.” The results from cytotoxicity, irritation and sensitization, systemic toxicity, genotoxicity, hemolysis, and subchronic and chronic implantation support the biocompatibity of the device. [21] In addition, P4HB devices have been tested extensively in pre-clinical studies to evaluate their safety profile, and more than 1 million patients worldwide have been implanted with P4HB devices with a very low number of complaints.[1]

Watch the Galatea Scaffold Collection Overview.

MonofilamentdotMonofilament

Galatea surgical scaffolds are designed with an open pore knit pattern to encourage rapid tissue
ingrowth throughout the macropores of the monofilament scaffold and to reduce risk of infection.[6,7,36,39]

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It has been reported that monofilament fibers have on average 60% less surface area than that of multifilament materials, which may improve the healing response.[18,37,38,39]

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With less surface area, monofilament scaffolds have fewer recesses that bacteria can use as a haven from the body’s natural defense systems or antibiotic treatments.[18,39,40]

When comparing SEM images of Galatea Surgical Scaffolds and other resorbable materials, the open pores, the smooth surface, and the monofilament structure of Galatea scaffolds are clearly visible.

Galatea Surgical Scaffold 20x Seri Scaffold 20x

VICRYL mesh 20x

Galatea Scaffolds
Monofilament derived from P4HB
SEM Photo, 20x
SERI® Scaffold
Multifilament
SEM Photo, 20x
TIGR® Mesh
Multifilament
SEM Photo, 20x
Woven VICRYL® Mesh
Multifilament
SEM Photo, 20x

StrongdotStrong

Galatea surgical scaffolds were designed for strength retention and rapid tissue ingrowth. In pre-clinical studies, a Galatea scaffold repair was shown to be at least three times the strength of the native tissue.[36] 

  • Galatea scaffold starts out strong and maintains about 70% of its strength at 12 weeks in vivo. [36]
  • As the scaffold bioresorbs, mechanical load is transferred to the new tissue, providing strength to the repair site.
  • By 26-32 weeks, the tissue from the scaffold repair site is 1-to 3mm thick and most of the repair strength is coming from new tissue. [36]
Long-Term Repair Strength in Preclinical Model

Galatea surgical scaffold acts as a lattice for new tissue growth, which is rapidly vascularized and fully integrated with adjacent tissue as Galatea scaffold fibers naturally bioresorb.

By 6 Weeks

  • Newly formed vascularized tissue is seen in the macroporous structure of the scaffold
  • The scaffold is embedded within mature fibrous and richly vascularized connective tissue (rich network of CD31, SMA, and Collagen III-positive blood vessels). [33]

By 7 Months

  • Tissue thickness has increased with minimal inflammatory response.
  • Type 1 collagen spans the entire length of the new tissue and is integrated with the scaffold. [33]

BioresorbabledotBioresorbable

The fully bioresorbable Galatea scaffold is constructed from a biopolymer that gradually and predictably degrades over the course of 18-24 months and is eliminated from the body as carbon dioxide and water. [23] Concurrently, the scaffold provides a lattice for new tissue ingrowth that gradually assumes the mechanical load of the site. Galatea scaffold is completely transitory and no polymer metabolites remain after the degradation process is complete.[33]

For more information on the bioresorption process of Galatea scaffold, click here.

Aesthetic Biologic Scaffolds Comparative Characteristics

Galatea scaffold provides strong support to help you achieve the desired surgical outcome. In comparison to commercially available Aesthetic Scaffolds for soft tissue support:

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The monofilament design of Galatea scaffold reduces risk of bacteria colonization and infection as compared to the complex structure of multifilament scaffolds that carry the risk of harboring bacteria and could inhibit the natural healing process. [18,39,40]

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The P4HB biopolymer of Galatea scaffold is bioresorbed primarily by hydrolysis whereas protein-based materials are resorbed enzymatically, which may resorb more quickly and prolongs the patient’s healing process. [18,39,40]

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At least 70% of Galatea scaffold strength is retained for 12 weeks; the critical wound healing period; whereas strength of other biomaterials is only retained for 1-3 months and may leave the repair site vulnerable.[36]

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Galatea scaffold acts as a lattice for tissue ingrowth and regeneration. Scaffolds that degrade too quickly may fail to repair the desired defect.

Disclaimer: The above discussion points are in the context of the general literature, and not indicative of results from a head-to-head study.

Estimated for 1cm probe from 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.

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