Image is not intended to represent the procedural result
GalaFLEX® is a biologically derived scaffold made of
poly-4-hydroxybutyrate (P4HB) that supports, elevates
and reinforces soft tissue in Breast Surgery.
Watch The Galatea Scaffold Family Overview here.
Instructions for Use
Paper copies are available upon request, please Contact Us at
contact-international@galateasurgical.com
Download Adobe Reader here.
Previous versions of the Instructions for
Use are available upon request.
Cannot find your IFU? Please contact us at
contact-international@galateasurgical.com
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 as needed. In contrast to other polymers used today for soft tissue support, P4HB is biologically derived through a proprietary biological fermentation process, rather than chemical synthesis.
Polymer accumulation inside the E. coli cells
P4HB has a unique set of properties, particularly in comparison to other fully absorbable polymers commonly used in resorbable medical devices, such as polyglycolide (PGA) and polylactide (PLA), which are inherently stiffer materials. The unique properties of P4HB make it possible to produce high strength pliable monofilament fibers, without sacrificing elasticity.
After the P4HB polymer is isolated and purified, it can be extruded into monofilament fibers and used directly as suture or knitted into macroporous scaffold configuration. P4HB scaffolds are designed to encourage rapid tissue in-growth and reduce the risk of infection.
P4HB devices have been tested in pre-clinical and clinical studies to evaluate safety and effectiveness [2,18,19]
More than 3 million patients worldwide have been implanted with P4HB devices.[1]
Disclaimer: The discussion points in the graphic (at right) are in the context of the general literature, and not indicative of results from a head-to-head study.
Properties
The Galatea Family of scaffolds offer a unique combination of properties that are designed for soft tissue reinforcement in breast surgery procedures.
Biologically Derived
Produced by a safe biological fermentation process,
standard in pharmaceutical production [12,17]
P4HB Molecule
Galatea Surgical Scaffolds are made from P4HB™
A macroporus, monofilament, fully absorbable scaffold with long term strength retention and predictable absorption profile, was exclusive in the field of plastic and reconstructive surgery until the development of Galatea scaffolds.
The Galatea team has created a family of scaffolds that offer a unique combination of properties utilizing non-cadaveric, non-human, non-animal, non-synthetic, biologically derived fully absorbable material: poly-4-hydroxybutyrate (P4HB) for plastic and reconstructive surgery procedures.
Monofilament
Designed to minimize risk of infection and
encourage a natural healing response [3,15]
The monofilament scaffold was designed with an open pore knit pattern to encourage rapid tissue ingrowth and to reduce risk of infection. [3,6,9]
- 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. [3,15]
- 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. [3,13]
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 Scaffolds
Monofilament derived from P4HB
SEM Photo, 20x
SEM Photo, 20x
TIGR® Mesh
Multifilament
SEM Photo, 20x
SEM Photo, 20x
Woven VICRYL® Mesh
Multifilament
SEM Photo, 20x
SEM Photo, 20x
Strong
Provides a lattice for new tissue ingrowth and regeneration
resulting in tissue 3-4x stronger than native tissue [9,16,19]
Galatea Surgical were designed specifically for rapid tissue regeneration and strength retention throughout the critical healing period. [1,9,19]
In pre-clinical studies this repair resulted in a new tissue plane approximately 3-4 times the strength of native tissue. [9,19]
- Galatea scaffold maintains greater than 70% of its strength at 12 weeks in vivo. [2]
- As the scaffold bioabsorbs, the new ingrown tissue provides strength to the repair site. [19]
- By 52 weeks the new ingrown tissue is approximately 2.4 mm thick and provides a majority of strength to the repair site. [2,23]
- By providing a lattice for tissue regeneration, the Galatea scaffold encourages cells to migrate into its pores, allowing stronger, organized collagen to be built and healthy blood vessels to form.[1,16]
By 6 Weeks
- New tissue with abundant mature collagen (as indicated by positive type I collagen staining) and vascularization (as shown by positive CD31 and smooth muscle actin stains) has quickly integrated into the scaffold. [1]
By 7 Months
- A fully integrated tissue plane of primarily type I collagen throughout the scaffold indicates collagen maturation and soft tissue regeneration (minimal inflammatory response with no evidence of encapsulation). [1]
Bioabsorbable
Galatea Scaffolds are constructed from P4HB which gradually and predictably bioabsorb over the course of 18-24 months. [2,12]
The scaffolds are broken down within the body primarily by the process of hydrolysis and ultimately eliminated as CO2 and H2O. [9,12]
As the scaffold bioabsorbs, the new ingrown tissue provides strength to the repair site. [19]
No polymer metabolites remain after the degradation process is complete. [2]
Comparative Scaffold Characteristics
Galatea scaffolds provides strong support to achieve the desired surgical outcome, in
comparison to commercially available soft tissue support scaffolds:
comparison to commercially available soft tissue support scaffolds:
The above discussion points are in the context of the general literature, and not indicative of results from a head-to-head study.
The Galatea Family of scaffolds offer a full portfolio of
shapes and sizes for the surgical needs of each patient.
A biologically derived fully absorbable scaffold that supports,
elevates and reinforces soft tissue in breast surgery.
The first and only shaped scaffold designed to elevate and provide lasting soft tissue support in breast surgery.
This unique 3D monofilament scaffold is made from the biologically derived poly-4-hydroxybutyrate (P4HB™), which naturally absorbs through hydrolysis.
The contoured design is easier to insert and suture in place, while reducing procedure time.
The only formed scaffold with a reinforcing rim that supports, elevates and reinforces breast tissue.
Information for your Patient
Image is not intended to represent the procedural result.
Help your patients make
an informed decision
You may know how GalaFLEX® can provide your patients
the internal support they require, but your patients may not.
Now you can give your surgical candidates the information
they need to make an informed decision with this
patient-focused guide. This brochure helps each patient
understand what GalaFLEX® is, why soft tissue support may be
important for a plastic surgery procedure, and why GalaFLEX®
may be an option to consider.
Empower your patients to choose strength and stability
when considering their internal support options. Download
the GalaFLEX® patient brochure today.
Image is not intended to represent the procedural result.
Galaflex® is a biologically derived scaffold made of poly-4-hydroxybutyrate (P4HB) that supports, elevates and reinforces soft tissue in Breast Surgery.
Paper copies are available upon
request, please Contact Us at
request, please Contact Us at
Download Adobe Reader here.
Previous versions of the Instructions for Use are available upon request.
Cannot find your IFU?
Please Contact Us at
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 as needed. In contrast to other polymers used today for soft tissue support, P4HB is biologically derived through a proprietary biological fermentation process, rather than chemical synthesis.
Polymer accumulation inside the E. coli cells
P4HB has a unique set of properties, particularly in comparison to other fully absorbable polymers commonly used in resorbable medical devices, such as polyglycolide (PGA) and polylactide (PLA), which are inherently stiffer materials. The unique properties of P4HB make it possible to produce high strength pliable monofilament fibers, without sacrificing elasticity.
After the P4HB polymer is isolated and purified, it can be extruded into monofilament fibers and used directly as suture or knitted into macroporous scaffold configuration. P4HB scaffolds are designed to encourage rapid tissue in-growth and reduce the risk of infection.
P4HB devices have been tested in pre-clinical and clinical studies to evaluate safety and effectiveness [2,18,19] .
More than 3 million patients worldwide have been implanted with P4HB devices.[1].
P4HB devices have been tested in pre-clinical and clinical studies to evaluate safety and effectiveness [2,18,19] .
More than 3 million patients worldwide have been implanted with P4HB devices.[1].
Disclaimer: The discussion points in the graphic (at right) are in the context of the general literature, and not indicative of results from a head-to-head study.
The Galatea Family of scaffolds offer a unique combination of properties that are designed for soft tissue reinforcement in breast surgery procedures.
Biologically Derived
Produced by a safe biological fermentation process, standard in pharmaceutical production [12,17]
P4HB Molecule
Galatea Surgical Scaffolds
are made from P4HB™
are made from P4HB™
A macroporus, monofilament, fully absorbable scaffold with long term strength retention and predictable absorption profile, was exclusive in the field of plastic and reconstructive surgery until the development of Galatea scaffolds.
The Galatea team has created a family of scaffolds that offer a unique combination of properties utilizing non-cadaveric, non-human, non-animal, non-synthetic, biologically derived fully absorbable material: poly-4-hydroxybutyrate (P4HB) for plastic and reconstructive surgery procedures.
The Galatea team has created a family of scaffolds that offer a unique combination of properties utilizing non-cadaveric, non-human, non-animal, non-synthetic, biologically derived fully absorbable material: poly-4-hydroxybutyrate (P4HB) for plastic and reconstructive surgery procedures.
Monofilament
Designed to minimize risk of infection and
encourage a natural healing response [3,15]
The monofilament scaffold was designed with an open pore knit pattern to encourage rapid tissue ingrowth and to reduce risk of infection. [3,6,9]
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. [3,15]
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. [3,13]
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 Scaffolds
Monofilament derived from P4HB
SEM Photo, 20x
SEM Photo, 20x
TIGR® Mesh
Multifilament
SEM Photo, 20x
SEM Photo, 20x
Woven VICRYL® Mesh
Multifilament
SEM Photo, 20x
SEM Photo, 20x
Strong
Provides a lattice for new tissue ingrowth and regeneration resulting in tissue 3-4x stronger than native tissue [9,16,19]
Galatea Surgical were designed specifically for rapid tissue regeneration and strength retention throughout the critical healing period. [1,9,19] In pre-clinical studies this repair resulted in a new tissue plane approximately 3-4 times the strength of native tissue. [9,19]
Galatea scaffold maintains greater than 70% of its strength at 12 weeks in vivo. [2]
As the scaffold bioabsorbs, the new ingrown tissue provides strength to the repair site. [19]
By 52 weeks the new ingrown tissue is approximately 2.4 mm thick and provides a majority of strength to the repair site. [2,23]
By providing a lattice for tissue regeneration, the Galatea scaffold encourages cells to migrate into its pores, allowing stronger, organized collagen to be built and healthy blood vessels to form.[1,16]
By 6 weeks
New tissue with abundant mature collagen (as indicated by positive type I collagen staining) and vascularization (as shown by positive CD31 and smooth muscle actin stains) has quickly integrated into the scaffold. [1]
By 7 months
A fully integrated tissue plane of primarily type I collagen throughout the scaffold indicates collagen maturation and soft tissue regeneration (minimal inflammatory response with no evidence of encapsulation). [1]
Bioabsorbable
Galatea Scaffolds are constructed from P4HB which gradually and predictably bioabsorb over the course of 18-24 months. [2,12]
The scaffolds are broken down within the body primarily by the process of hydrolysis and ultimately eliminated as CO2 and H2O. [9,12]
As the scaffold bioabsorbs, the new ingrown tissue provides strength to the repair site. [19] No polymer metabolites remain after the degradation process is complete. [2]
The scaffolds are broken down within the body primarily by the process of hydrolysis and ultimately eliminated as CO2 and H2O. [9,12]
As the scaffold bioabsorbs, the new ingrown tissue provides strength to the repair site. [19] No polymer metabolites remain after the degradation process is complete. [2]
Comparative Scaffold Characteristics
Galatea scaffolds provides strong support to achieve the desired surgical outcome, in comparison to commercially available soft tissue support scaffolds:
The above discussion points are in the context of the general literature, and not indicative of results from a head-to-head study.
The Galatea Family of scaffolds offer a full portfolio of shapes and sizes for the surgical needs of each patient.
A biologically derived fully absorbable scaffold that supports, elevates and reinforces soft tissue in breast surgery.
After implantation, the scaffold gradually and predictably bioabsorbs 12 while supporting tissue ingrowth, resulting in tissue 3-4 times stronger than native tissue 9,16,19
The first and only shaped scaffold designed to elevate and provide lasting soft tissue support in breast surgery.
This unique 3D monofilament scaffold is made from the biologically derived poly-4-hydroxybutyrate (P4HB™), which naturally absorbs through hydrolysis.
The contoured design is easier to insert and suture in place, while reducing procedure time.
The only formed scaffold with a reinforcing rim that supports, elevates and reinforces the breast tissue.
Help your patients make an informed decision
You may know how GalaFLEX® can provide your patients the internal support they require, but your patients may not.
Now you can give your surgical candidates the information they need to make an informed decision with this patient-focused guide. This brochure helps each patient understand what GalaFLEX® is, why soft tissue support may be important for a plastic surgery procedure, and why GalaFLEX® may be an option to consider.
Empower your patients to choose strength and stability when considering their internal support options. Download the GalaFLEX®patient brochure today.
Now you can give your surgical candidates the information they need to make an informed decision with this patient-focused guide. This brochure helps each patient understand what GalaFLEX® is, why soft tissue support may be important for a plastic surgery procedure, and why GalaFLEX® may be an option to consider.
Empower your patients to choose strength and stability when considering their internal support options. Download the GalaFLEX®patient brochure today.
