THE NEXT PHASE IN HERNIA REPAIR
,High repair strength through the critical healing phase
Composed of biologically-derived material, Poly-4-hydroxybutyrate (P4HB), Phasix™ Mesh provides critical strength during the initial healing phase with rapid tissue ingrowth and vascularization through its open-pore monofilament structure. The open monofilament mesh scaffold also provides early integration and repair strength*
,ORGANIZED AND FUNCTIONAL COLLAGEN AT HERNIA REPAIR SITE
,Preclinical testing confirms vascular integration and incorporation, with abundant mature collagen at 52 weeks. Gradually transfers load to native tissue over time*
Rapid tissue incorporation
Predictable strength for the long run
Phasix™ Mesh gradually and predictably degrades within 12 to 18 months via hydrolysis leaving behind a durable, functional repair with over 3x the strength of the native abdominal wall.
,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
,PROMISING RESULTS IN THE PRESENCE OF BACTERIA
,- Phasix™ Mesh has not been shown to break down in the presence of bacteria—maintaining 100% of its strength at 56 days —unlike biologic grafts which demonstrate accelerated degradation in the presence of bacteria.
- As shown in the graphic below, there was no presence of bacterial colonization observed in Phasix Mesh™ or Phasix™ ST Mesh 7 days post-inoculation in preclinical testing. The other side of this graph shows the Presence of abscess (white material) observed SurgiMend®, Strattice™, Bio - A ®, and OviTex™. Other observed indications of bacterial colonization included swelling, the presence of fluids, and thickened capsule tissue.
,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
,Prospective Multi-institutional Evaluation of Phasix™ Mesh in High Risk Ventral and Incisional Hernia Repairs: 18 month follow up. (Click on image to expand).
,PROVEN PERFORMANCE FROM A RELIABLE PARTNER
,With over 143,000 implants across the Phasix™ Mesh family,11 BD is proud to be the category leader for hernia repair and bioresorbable mesh. BD is committed to providing an innovative hernia portfolio that focuses on improving clinical outcomes for better patient care.
The Phasix™ Mesh family is reliable and used around the globe:
- Over 143,000 implants
- More than 10 clinical studies
- More than 950 patients studied
- Proven clinical outcomes at 3 years
The Phasix™ Mesh family also offers the following benefits
- Low recurrence
- Low surgical site infection (SSI)
- Low seroma rates
- Associated with improved quality of life
