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Phasix™ Mesh

Fully Resorbable Implant for Soft Tissue Reconstruction

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Overview

Designed to enable constructive and functional tissue remodeling1

Phasix™ Mesh provides a fully resorbable monofilament scaffold for rapid tissue incorporation that has been designed to allow for the repair strength of a synthetic mesh along with the remodeling characteristics of a biologic graft.1

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Features and Benefits
THE NEXT PHASE IN HERNIA REPAIR
THE NEXT PHASE IN HERNIA REPAIR

Repairs1

The open monofilament mesh scaffold provides early integration and repair strength*

Remodels1

Preclinical testing confirms vascular integration and incorporation, with abundant mature collagen at 52 weeks. Gradually transfers load to native tissue over time*

Restores1

As Phasix™ Mesh is remodeled, it is replaced with functional tissue, ultimately resulting in a strong repair at one year*

WHAT IS PHASIX™ MESH?

Phasix™ Mesh is a knitted monofilament mesh scaffold using Poly-4-hydroxybutyrate (P4HB), a biologically derived, fully resorbable material.

Monomer form (4HB) is a naturally occurring human metabolite found in the brain, heart, liver, kidney, and muscle

Predictably resorbs through hydrolysis, as P4HB metabolizes into biocompatible byproducts (CO2 and H2O)4

MATERIAL STRUCTURE1

  • Material structure can impact host response.5 Consider these features of monofilament versus multifilament structures:
  • Monofilament mesh design allows for a prompt fibroblastic response through the open interstices of the mesh1

 

  • 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 response6
  • It has been reported that the surface area of multifilament material is 157% higher than monofilament materials6

TISSUE INCORPORATION1

  • Study objective: Evaluate material strength and histopathology of Phasix™ Mesh.
  • Study design: A 3-centimeter round defect was created in the ventral abdominal wall of 25 Yucatan mini-pigs (average weight 38 kg). Phasix™ Mesh was fixated directly over the defect with SorbaFix™ resorbable tacks. Ball burst testing and histopathology were conducted at 6, 12, 26, and 52 weeks.

    Results:

    Early tissue ingrowth, vascular integration, and incorporation of Phasix™ Mesh into the ventral abdominal wall, plus abundant mature collagen formed around the remaining fibers at 52 weeks.

CLINICAL
CLINICAL

Prospective Multi-institutional Evaluation of Phasix™ Mesh in High Risk Ventral and Incisional Hernia Repairs: 18 month follow up. (Click on image to expand).

Reference

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

2. Deeken CR, Abdo MS, Frisella MM, Matthews BD. “Physicomechanical evaluation of absorbable and nonabsorbable barrier composite meshes for laparoscopic ventral hernia repair.” Surgical Endoscopy 25.5 (2010): 1541-552.

3. Estimated from Standard Curve in (Martin DP, et al. “Characterizationof poly-4-hydroxybutyrate mesh for hernia repair applications.” Journal of Surgical Research. 2013; (184): 766-773

4. Martin, DP. et al. “ Medical applications of poly-4-hydroxybutyrate:a strong flexible absorbable biomaterial. Biochemical Engineering Journal. 2002; December 9

5. Amid PK, Shulman AG, Lichtenstein IL, Hakaha M. Biomaterials for Abdominal Wall Hernia Surgery and Principles of their Applications. Langenbecks Archive Chir. 1994; 379(3): 168-71.

6. Halaweish I, Harth K, Broome AM, Voskerician G, Jacobs MR, Rosen M. Novel In Vitro Model for Assessing Susceptibility of Synthetic Hernia Repair Meshes to Staphylococcus aureus Infection Using Green Fluorescent Protein-Labeled Bacteria and Modern Imaging Techniques. J Surg Infect (Larchmt). 2010; Oct1(5): 449-54.

Indications

Phasix™ Mesh is indicated 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 hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

Contraindications

Because Phasix™ Mesh is fully resorbable, it should not be used in repairs where permanent wound or organ support from the mesh is required.

Warnings

Phasix™ Mesh must not be put in direct contact with bowel or viscera. The safety and product use for patients with hypersensitivities to tetracycline hydrochloride or kanamycin sulfate is unknown. Use of this device in patients with known allergies to these antibiotics should be avoided. The safety and effectiveness of Phasix™ Mesh in pediatric use has not been evaluated or established. If an infection develops, treat the infection aggressively. An unresolved infection may require removal of the device.

Adverse Reactions

Possible complications include infection, seroma, pain, mesh migration, wound dehiscence, hemorrhage, adhesions, hematoma, inflammation, allergic reaction, extrusion, erosion, fistula formation and recurrence of the hernia or soft tissue defect.

Please consult package insert for more detailed safety information and instructions for use.

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BD-16443

Products & Accessories
  • product-image

    Phasix™ Mesh, Rectangle, 4 in x 8 in (10 cm x 20 cm)

  • product-image

    Phasix™ Mesh, Rectangle, 6 in x 12 in (15 cm x 30 cm)

  • product-image

    Phasix™ Mesh, Square, 19.5 in x 19.5 in (50 cm x 50 cm)

  • product-image

    Phasix™ Mesh, Square, 16 in x 16 in (40 cm x 40 cm)

  • product-image

    Phasix™ Mesh, Square, 3 in x 3 in (8 cm x 8 cm)

  • product-image

    Phasix™ Mesh, Rectangle, 4 in x 10 in (10 cm x 25 cm)

  • product-image

    Phasix™ Mesh, Rectangle, 8 in x 16 in (20 cm x 40 cm)

  • product-image

    Phasix™ Mesh, Square, 14 in x 14 in (35 cm x 35 cm)

  • product-image

    Phasix™ Mesh, Rectangle, 12 in x 18 in (30 cm x 45 cm)

  • product-image

    Phasix™ Mesh, Square, 18 in x 18 in (45 cm x 45 cm)

  • product-image

    Phasix™ Mesh, Rectangle, 4 in x 6 in (10.2 cm x 15.2 cm)

  • product-image

    Phasix™ Mesh, Round, 3 in (7.6 cm)

  • product-image

    Phasix™ Mesh, Rectangle, 10 in x 16 in (25 cm x 40 cm)

  • product-image

    Phasix™ Mesh, Rectangle, 2.4 in x 6.3 in (6 cm x 16 cm)

  • product-image

    Phasix™ Mesh, Rectangle, 6 in x 8 in (15.2 cm x 20.3 cm)

  • product-image

    Phasix™ Mesh, Square, 12 in x 12 in (30 cm x 30 cm)

  • product-image

    Phasix™ Mesh, Rectangle, 3 in x 6.3 in (8 cm x 16 cm)

  • product-image

    Phasix™ Mesh, Rectangle, 3 in x 8 in (8 cm x 20 cm)

  • product-image

    Phasix™ Mesh, Rectangle, 6 in x 10 in (15 cm x 25 cm)

  • product-image

    Phasix™ Mesh, Round, 4.5 in (11 cm)

  • product-image

    Phasix™ Mesh, Rectangle, 8 in x 12 in (20 cm x 30 cm)

  • product-image

    Phasix™ Mesh, Square, 8 in x 8 in (20 cm x 20 cm)

  • product-image

    Phasix™ Mesh, Square, 4 in x 4 in (10 cm x 10 cm)

  • product-image

    Phasix™ Mesh, Rectangle, 10 in x 12 in (25.4 cm x 30.5 cm)

  • product-image

    Phasix™ Mesh, Rectangle, 8 in x 10 in (20.3 cm x 25.4 cm)

Related Products

References

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

2. Deeken CR, Abdo MS, Frisella MM, Matthews BD. “Physicomechanical evaluation of absorbable and nonabsorbable barrier composite meshes for laparoscopic ventral hernia repair.” Surgical Endoscopy 25.5 (2010): 1541-552.

3. Estimated from Standard Curve in (Martin DP, et al. “Characterizationof poly-4-hydroxybutyrate mesh for hernia repair applications.” Journal of Surgical Research. 2013; (184): 766-773

4. Martin, DP. et al. “ Medical applications of poly-4-hydroxybutyrate:a strong flexible absorbable biomaterial. Biochemical Engineering Journal. 2002; December 9

5. Amid PK, Shulman AG, Lichtenstein IL, Hakaha M. Biomaterials for Abdominal Wall Hernia Surgery and Principles of their Applications. Langenbecks Archive Chir. 1994; 379(3): 168-71.

6. Halaweish I, Harth K, Broome AM, Voskerician G, Jacobs MR, Rosen M. Novel In Vitro Model for Assessing Susceptibility of Synthetic Hernia Repair Meshes to Staphylococcus aureus Infection Using Green Fluorescent Protein-Labeled Bacteria and Modern Imaging Techniques. J Surg Infect (Larchmt). 2010; Oct1(5): 449-54.

Indications

Phasix™ Mesh is indicated 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 hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

Contraindications

Because Phasix™ Mesh is fully resorbable, it should not be used in repairs where permanent wound or organ support from the mesh is required.

Warnings

Phasix™ Mesh must not be put in direct contact with bowel or viscera. The safety and product use for patients with hypersensitivities to tetracycline hydrochloride or kanamycin sulfate is unknown. Use of this device in patients with known allergies to these antibiotics should be avoided. The safety and effectiveness of Phasix™ Mesh in pediatric use has not been evaluated or established. If an infection develops, treat the infection aggressively. An unresolved infection may require removal of the device.

Adverse Reactions

Possible complications include infection, seroma, pain, mesh migration, wound dehiscence, hemorrhage, adhesions, hematoma, inflammation, allergic reaction, extrusion, erosion, fistula formation and recurrence of the hernia or soft tissue defect.

Please consult package insert for more detailed safety information and instructions for use.

true

BD-16443

Resources
References

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

2. Deeken CR, Abdo MS, Frisella MM, Matthews BD. “Physicomechanical evaluation of absorbable and nonabsorbable barrier composite meshes for laparoscopic ventral hernia repair.” Surgical Endoscopy 25.5 (2010): 1541-552.

3. Estimated from Standard Curve in (Martin DP, et al. “Characterizationof poly-4-hydroxybutyrate mesh for hernia repair applications.” Journal of Surgical Research. 2013; (184): 766-773

4. Martin, DP. et al. “ Medical applications of poly-4-hydroxybutyrate:a strong flexible absorbable biomaterial. Biochemical Engineering Journal. 2002; December 9

5. Amid PK, Shulman AG, Lichtenstein IL, Hakaha M. Biomaterials for Abdominal Wall Hernia Surgery and Principles of their Applications. Langenbecks Archive Chir. 1994; 379(3): 168-71.

6. Halaweish I, Harth K, Broome AM, Voskerician G, Jacobs MR, Rosen M. Novel In Vitro Model for Assessing Susceptibility of Synthetic Hernia Repair Meshes to Staphylococcus aureus Infection Using Green Fluorescent Protein-Labeled Bacteria and Modern Imaging Techniques. J Surg Infect (Larchmt). 2010; Oct1(5): 449-54.

Indications

Phasix™ Mesh is indicated 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 hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

Contraindications

Because Phasix™ Mesh is fully resorbable, it should not be used in repairs where permanent wound or organ support from the mesh is required.

Warnings

Phasix™ Mesh must not be put in direct contact with bowel or viscera. The safety and product use for patients with hypersensitivities to tetracycline hydrochloride or kanamycin sulfate is unknown. Use of this device in patients with known allergies to these antibiotics should be avoided. The safety and effectiveness of Phasix™ Mesh in pediatric use has not been evaluated or established. If an infection develops, treat the infection aggressively. An unresolved infection may require removal of the device.

Adverse Reactions

Possible complications include infection, seroma, pain, mesh migration, wound dehiscence, hemorrhage, adhesions, hematoma, inflammation, allergic reaction, extrusion, erosion, fistula formation and recurrence of the hernia or soft tissue defect.

Please consult package insert for more detailed safety information and instructions for use.

true

BD-16443

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