GalaFlex

/GalaFlex
GalaFlex 2017-10-25T11:46:00+00:00

GalaFLEX Mesh – Strength & Beauty. Inside & Out

Finally! Everything you need when supporting soft tissue; nothing you don’t.

Discover the Next Generation in Surgical Scaffolds for Soft Tissue Regeneration

GalaFLEX 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. GalaFLEX 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.

Unique Properties

GalaFLEX scaffold offers a unique combination of properties that are optimal for soft tissue reinforcement in plastic and reconstructive surgery:

  • Biologically Derived – Produced by a safe and natural process, standard in pharmaceutical Production.
  • Monofilament – Designed to minimize risk of infection and encourages a healing response.
  • Strong – Provides a lattice for new tissue ingrowth and regeneration resulting in tissue 3-5x stronger than native tissue.
  • Bioresorbable – Naturally broken down to CO2 and H2O, with full bioresorption by 18-24 months.

Biologically Derived

Produced by a safe and natural biological fermentation process, standard to antibiotic and vaccine production, designed for biocompatibility and a minimal inflammatory response.

GalaFLEX biologically derived P4HB construction

  • Proprietary fermentation process designed and optimized to provide a safe, biologically friendly product that when combined with all other features encourages the patient’s natural healing response.
  • P4HB has been tested in pre-clinical and clinical studies to evaluate its safety and efficacy.
  • More than 1 million patients worldwide have P4HB devices implanted, and results indicate a strong safety profile.

Monofilament

Knitted with an open-pore design to encourage tissue in-growth and healing and to reduce the risk of bacterial colonization.

GalaFLEX macroporous, monofilament scaffold design

  • Knitted with an open pore design to reduce risk of infection and encourage rapid tissue ingrowth and healing throughout the macropores of the monofilament scaffold.
  • Monofilament fibers have 60% less surface area than multifilament material, which may improve the host’s healing response.
  • 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.

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Strong

Provides a lattice for new tissue ingrowth with the resulting tissue 3-5x stronger than native tissue.

GalaFLEX strength retention

  • Designed specifically for strength retention throughout the critical wound healing phase and rapid tissue regeneration.
  • 3-5 times the strength of the native tissue as demonstrated in pre-clinical studies.

GalaFLEX encourages new tissue ingrowth and regeneration

  • Provides a lattice for new tissue ingrowth.
  • Maintains ~70% of its strength at 12 weeks in vivo.
  • Transfers strength to new tissue, contributing 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.

Long-Term Repair Strength in a Preclinical Model

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Before Implantation

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GalaFLEX scaffold is a macroporous, monofilament, bioresorbable scaffold.

After Implantation

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Tissue ingrowth occurs into the pores and through the GalaFLEX scaffold, such that the newly formed tissue is well integrated within the scaffold.

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The newly formed tissue that infiltrates the GalaFLEX scaffold is pliable and provides strength to support the elevated tissue.

Bioresorbable

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

GalaFLEX fully bioresorbable polymer

  • Naturally bioresorbed, leaving behind only a strong, healthy tissue to support the surgical outcome.
  • Gradually and predictably bioresorbs over the course of 18-24 months.
  • Eliminated from the body as carbon dioxide and water primarily by the process of hydrolysis.
  • No polymer metabolites remain after the degradation process is complete ie. (GalaFLEX is completely transitory).

Collagen Formation & Vascularisation

GalaFLEX provides a lattice for tissue regeneration, encouraging cells to migrate into its pores, allowing collagen to build and healthy blood vessels to form.

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  • 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).
  • By 7 Months2

    • 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.

What is P4HB?

P4HB belongs to a large group of naturally occurring biopolymers, known as polyhydroxyalkanoates (PHAs). PHAs exist in nature as energy reserves in microorganisms that can be stored up and broken down when needed.

In contrast to other polymers used today for soft tissue support, P4HB is produced through a proprietary biologic fermentation process, rather than chemical synthesis.

P4HB has a very unique set of properties, particularly in comparison to other polymers commonly used in resorbable medical devices, such as polyglycolide (PGA) and polylactide (PLA), which are inherently much stiffer materials. The properties of P4HB make it possible to produce high strength biomaterial without sacrificing elasticity to yield strong, pliable monofilament fibers.

Aesthetic Biologic Scaffolds: Comparative Characteristics

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GalaFLEX: Available Sizes & Shapes

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