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Phasix™ Mesh Image

Phasix™ Mesh Image
Phasix™ Mesh

Fully Resorbable Implant for Soft Tissue Reconstruction

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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

Phasix Animation

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)1

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

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THE NEXT PHASE IN HERNIA REPAIR

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

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

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

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

Phasix Chart

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.

MATERIAL STRUCTURE1

Material structure can impact host response.2 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 response3
  • It has been reported that the surface area of multifilament material is 157% higher than monofilament materials3

1 Preclinical data on file; results may not correlate to clinical performance in humans.
2 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.
3 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.

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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.

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

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CLINICAL

Prospective Multi-institutional Evaluation of Phasix™ Mesh in High Risk Ventral and Incisional Hernia Repairs:

  • 18 month follow-up (Full publication now available in Surgical Endoscopy) available here.
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BioSurgery Surgical Education

The following pages will introduce you to Bard’s BioSurgical Education modalities and faculty. We are committed to advanced professional education – helping you choose the right products and procedures to provide the right outcomes for your patients.

Soft Tissue Repair Education

Bard® Surgical Education Programs are designed to provide you with focused and flexible modalities providing in-depth education on products and techniques intended to help you optimize patient care.

Selecting a partner for surgical products can be a difficult decision. There is a lot at stake for many people in your organization, including Operating Room Managers, Surgeons, Materials Management and of course your patients. For this reason Bard Davol provides information on our products and product portfolios that help you simplify the selection process and puts pertinent, important information at your finger tips.

Our commitment to your success extends beyond the OR. We also offer access to our Customer Service, Medical Services and Support, Reimbursement Hotline and our world-class Surgeon Education groups. These are resources Bard Davol invests in for your success, staffed by experts who are passionate about offering you the best service and experience possible.

For more information, visit: http://www.davol.com/value-analysis/

Specifications

Product Item IDProduct Item NamePackaging (SKU)Dimensions
1190100Phasix™ Mesh1/cs.3”x 3" Round (7.6 cm Round)
1190200Phasix™ Mesh1/cs.4”x 6” Rectangle (10.2 cm x 15.2 cm)
1190011Phasix™ Mesh1/cs.4.5" Round (11 cm)
1190808Phasix™ Mesh1/cs.3" x 3" Square (8 x 8 cm)
1190616Phasix™ Mesh1/cs.2.4" x 6.3" Rectangle (6 x 16 cm)
1190816Phasix™ Mesh1/cs.3" x 6.3" Rectangle (8 x 16 cm)
1190820Phasix™ Mesh1/cs.3" x 8" Rectangle (8 x 20 cm)
1191010Phasix™ Mesh1/cs.4" x 4" Square (10 x 10 cm)
1191020Phasix™ Mesh1/cs.4" x 8" Rectangle (10 x 20 cm)
1191025Phasix™ Mesh1/cs.4" x 10" Rectangle (10 x 25 cm)
1190300Phasix™ Mesh1/cs.6" x 8" Rectangle (15.2 x 20.3 cm)
1191525Phasix™ Mesh1/cs.6" x 10" Rectangle (15 x 25 cm)
1192020Phasix™ Mesh1/cs.8" x 8" Square (20 x 20 cm)
1191530Phasix™ Mesh1/cs.6" x 12" Rectangle (15 x 30 cm)
1190400Phasix™ Mesh1/cs.8" x 10" Rectangle (20.3 x 25.4 cm)
1192030Phasix™ Mesh1/cs.8" x 12" Rectangle (20 x 30 cm)
1192040Phasix™ Mesh1/cs.8" x 16" Rectangle (20 x 40 cm)
1190500Phasix™ Mesh1/cs.10" x 12" Rectangle (25.4 x 30.5 cm)
1193030Phasix™ Mesh1/cs.12" x 12" Square (30 x 30 cm)
1192540Phasix™ Mesh1/cs.10" x 16" Rectangle (25 x 40 cm)
1193045Phasix™ Mesh1/cs.12" x 18" Rectangle (30 x 45 cm)
1193535Phasix™ Mesh1/cs.14" x 14" Square (35 x 35 cm)
1194040Phasix™ Mesh1/cs.16" x 16" Square (40 x 40 cm)
1194545Phasix™ Mesh1/cs.18" x 18" Square (45 x 45 cm)
1195050Phasix™ Mesh1/cs.19.5" x 19.5" Square (50 x 50 cm)

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

 

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