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Learn more about our portfolio

GalaFLEX™ Scaffold Collection

The GalaFLEX™ Scaffold is a biologically-derived 2D scaffold for plastic and reconstructive surgery designed to provide immediate soft tissue reinforcement and a foundation for long-term strength.

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Support, elevate and reinforce soft tissue

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GalaFLEX™ Scaffold

Portfolio sizes

Available in five select sizes to meet various patient needs.

GalaFLEX™ Scaffold

Available in five select sizes to meet various patient needs.

Portfolio sizes

The GalaFLEX™ Scaffold is a biologically-derived 2D scaffold for plastic and reconstructive surgery designed to provide immediate soft tissue reinforcement and a foundation for long-term strength.

1-5

Indication for use

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.​

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Important safety information

Possible complications following implantation of the GalaFLEX™ Scaffold collection include infection, seroma, pain, scaffold migration, wound dehiscence, hemorrhage, adhesions, hematoma, inflammation, extrusion and recurrence of the soft tissue defect. In pre-clinical testing, the GalaFLEX™ Scaffold collection elicited a minimal tissue reaction characteristic of foreign body response to a substance. The tissue reaction resolved as the scaffold was resorbed. For complete prescribing information, including indications for use, warnings and precautions, consult the specific GalaFLEX™ Scaffold product Instructions for Use.

References

  1. Preclinical data on file. Results may not correlate to clinical outcomes.  

  2. 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. Published 2013 May 28. doi:10.1155/2013/238067                                             

  3. Scott JR, Deeken CR, Martindale RG, Rosen MJ. Evaluation of a fully absorbable poly-4-hydroxybutyrate/absorbable barrier composite mesh in a porcine model of ventral hernia repair. Surg Endosc. 2016;30(9):3691-3701. doi:10.1007/s00464-016-5057-9                 

  4. Martin DP, Badhwar A, Shah DV, et al. Characterization of poly-4-hydroxybutyrate mesh for hernia repair applications. J Surg Res. 2013;184(2):766-773.  doi:10.1016/j.jss.2013.03.044

  5. GalaFLEX™ Scaffold Instructions for use.

  6. Based on surgeon feedback.​

GalaFLEX LITE™ Scaffold

Low profile scaffold. Predictable P4HB strength.
Lightweight does not mean weak.¹

Just like the GalaFLEX™ Scaffold collection, GalaFLEX LITE™ Scaffold was designed to provide support to newly repaired tissue immediately after surgery and in preclinical studies has demonstrated strength retention throughout the critical wound healing period.     Although it is approximately 30% thinner, GalaFLEX LITE™ Scaffold has approximately 90% of the initial strength of GalaFLEX™ Scaffold.

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Provides a lattice for new tissue ingrowth, resulting in a tissue plane that is 2x stronger than native tissue.

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Maintains strength during gradual transfer of load to ingrown tissue, with bioabsorption essentially complete in 18-24 months.¹

Available in many shapes and sizes

with options for varying patient needs.

Indication for use

GalaFLEX LITE™ Scaffold is intended to reinforce soft tissue where weakness exists in patients undergoing plastic and reconstructive surgery, or for use in procedures involving soft tissue repair, such as the repair of fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

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Important safety information

Possible complications following implantation of the GalaFLEX™ Scaffold collection and GalaFLEX LITE™ Scaffold include infection, seroma, pain, scaffold migration, wound dehiscence, hemorrhage, adhesions, hematoma, inflammation, extrusion and recurrence of the soft tissue defect. In pre-clinical testing, the GalaFLEX™ Scaffold collection and GalaFLEX LITE™ Scaffold elicited a minimal tissue reaction characteristic of foreign body response to a substance. The tissue reaction resolved as the scaffold was resorbed. For complete prescribing information, including indications for use, warnings and precautions, consult the specific GalaFLEX™ Scaffold and GalaFLEX LITE™ Scaffold product Instructions for Use.

References

  1.  Preclinical data on file. Results may not correlate to clinical outcomes.  

  2. Ireton JE, Unger JG, Rohrich RJ. The role of wound healing and its everyday application in plastic surgery: a practical perspective and systematic review. Plast Reconstr Surg Glob Open. 2013;1(1):e10-e19. Published 2013 May 7. doi:10.1097/GOX.0b013e31828ff9f4

  3. Critical wound healing period adapted from Ireton 2013 (6 weeks to 3 months).  

  4. Based on surgeon feedback.

  5. 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. Published 2013 May 28. doi:10.1155/2013/238067.

GalaFLEX 3D™ Scaffold

Robust portfolio of shapes and sizes
Offered in 3D shapes and sizes designed to fit and elevate the body's natural shape.

GalaFLEX 3D™ Scaffold is the first and only formed absorbable scaffold designed to fit and elevate the body's natural shape, providing easier placement and potentially reduced procedure time.

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Indication for use

GalaFLEX 3D™ 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 3D™ 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.

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Important safety information

Possible complications following implantation of the GalaFLEX™ Scaffold collection include infection, seroma, pain, scaffold migration, wound dehiscence, hemorrhage, adhesions, hematoma, inflammation, extrusion and recurrence of the soft tissue defect. In pre-clinical testing, the GalaFLEX™ Scaffold collection elicited a minimal tissue reaction characteristic of foreign body response to a substance. The tissue reaction resolved as the scaffold was resorbed. For complete prescribing information, including indications for use, warnings and precautions, consult the specific GalaFLEX™ Scaffold product Instructions for Use.

References

  1. Preclinical data on file. Results may not correlate to clinical performance in humans.

  2. GalaFLEX 3D™ Instructions for Use.

  3. Based on surgeon feedback.​

GalaFLEX 3DR™ Scaffold

Portfolio of sizes
Offered in multiple 3D sizes designed to fit and elevate the body’s natural shape​.

GalaFLEX 3DR™ Scaffold is the only 3-dimensional scaffold with a reinforcing rim to ease scaffold placement, allowing for potentially reduced procedure time and support by conforming to the patient’s natural shape.

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Indication for use

GalaFLEX 3DR™ 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 3DR™ 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.

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Important safety information

Possible complications following implantation of the GalaFLEX™ Scaffold collection include infection, seroma, pain, scaffold migration, wound dehiscence, hemorrhage, adhesions, hematoma, inflammation, extrusion and recurrence of the soft tissue defect. In pre-clinical testing, the GalaFLEX™ Scaffold collection elicited a minimal tissue reaction characteristic of foreign body response to a substance. The tissue reaction resolved as the scaffold was resorbed. For complete prescribing information, including indications for use, warnings and precautions, consult the specific GalaFLEX™ Scaffold product Instructions for Use.

References

  1. Preclinical data on file. Results may not correlate to clinical performance in humans.

  2. GalaFLEX 3DR™ Scaffold Instructions for Use

  3. Based on surgeon feedback.​

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