BiologicallyderiveddotBiologically Derived

Galatea surgical scaffold is made from P4HB™ BiopolyWoman-Scarf-Stillmer.  This biopolymer is produced through a 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.

Watch the Galatea Scaffold Collection Overview.

MonofilamentdotMonofilament

Galatea surgical scaffold is constructed from monofilament P4HB fibers. Because the structure of a scaffold may impact host response, [24] consider these features of monofilament versus multifilament structures:

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It has been reported that the surface area of multifilament material is 157% higher than monofilament materials. [18]

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Material designs with complex architecture can have greater surface area and niches that bacteria can use as a haven from tissue ingrowth, neovascularization, antibiotic treatment, and host inflammatory response. [18]

In addition to low bacterial adherence, the monofilament design of Galatea surgical scaffolds allows for rapid tissue ingrowth throughout the macropores of the scaffold.

GalaFlex Monofilament Surgical Scaffold - 20x Magnification

Galatea Surgical Scaffold Monofilament Construction

SEM Photo 20x

SERI® Surgical Scaffold: Multifilament Scaffold derived from silk

SEM Photo, 17x

StrongdotStrong

Galatea surgical scaffold was 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.  

  • Galatea scaffold starts out strong and maintains about 70% of its strength at 12 weeks in vivo. [33]
  • As Galatea scaffold loses strength, new ingrown tissue starts to contribute to the mechanical strength of 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. [33]
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.

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:

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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. [24]

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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. [24]

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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.

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

* Data on file at Tepha, Inc.

** 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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