Phasix™ ST Mesh combines two market-leading technologies into one product: monofilament resorbable Phasix™ Mesh and a proven hydrogel barrier based on Sepra® technology. While the monofilament mesh supports functional healing and a strong repair, the hydrogel barrier minimizes tissue attachment to the visceral side of the mesh for intraabdominal placement.1

Why Phasix™ ST?

1 Preclinical data on file; results may not correlate to clinical performance in humans.
2 Internal market research, data on file, 2015.
3 Liang MK, Li LT, Nguyen MT, Berger RL, Hicks SC, Kao LS. “Abdominal reoperation and mesh explantation following open ventral hernia repair with mesh.” The American Journal of Surgery 208.4 (2014): 670-76.
4 Itani KM, et al. “Prospective study of single-stage repair of contaminated hernias using a biologic porcine tissue matrix: the RICH Study.” Surgery 2012; 152(3): 498-505.
5 Annor AH, Tang ME, Pui CL, Ebersole GC, Frisella MM, Matthews BD, Deeken CR. “Effect of enzymatic degradation on the mechanical properties of biological scaffold materials.” Surgical Endoscopy 26.10 (2012): 2767-778.
6 Harth KC, et al. “Effect of surgical wound classification on biologic graft performance in complex hernia repair: an experimental study.” Surgery 2013; 153(4): 481-492.

The Next Phase in Hernia Repair

Repairs. *
The open monofilament mesh structure provides early integration and repair strength.1
 

Remodels. *
Vascular integration and incorporation continues, with abundant mature collagen at 52 weeks. Gradually transfers load to native tissue over time. 1
 

Restores*
As Phasix™ Mesh is remodeled, it is replaced with functional tissue, ultimately resulting in a strong repair at one year.1
 

 

1 Preclinical data on file at C. R. Bard, Inc. Phasix™ ST Mesh shows similar mechanical strength over time to Phasix™ Mesh in a preclinical model. Results may not correlate to clinical performance in humans.
2 Preclinical data on file. Results may not correlate to clinical performance in humans.
3 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 Surgery 2013; 1-12.
4 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.
5 Estimated from Standard Curve in manuscript (Martin, et al. JSR 2013).

What is Phasix™ ST Mesh? 

Phasix™ ST Mesh combines two market-leading technologies into one product: monofilament resorbable Phasix™ Mesh and a proven hydrogel barrier based on Sepra® technology.

Phasix™ Mesh

  •  Biologically derived monofilament scaffold: Poly-4-hydroxybuterate (P4HB)

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

  • P4HB scaffold has been used clinically for hernia repair for 5 years7

Sepra® Hydrogel Barrier

  • Hydrogel barrier on posterior side minimizes visceral tissue attachment1

  • Uncoated P4HB monofilament allows for tissue ingrowth on the anterior side1

  • Resorbs within 30 days1

  • Used clinically since 2007


Click Here to learn more about Phasix™ Mesh
 

Material Structure1

Monofilament mesh designs have been deemed more biocompatible and less susceptible to bacterial adherence and colonization.2,3,4,5,6 

 


1 Preclinical data on file at C. R. Bard, Inc. Results may not correlate to clinical performance in humans.
2 Nguyen PT, Asarias JR, Pierce LM. “Influence of a new monofilament polyester mesh on inflammation and matrix remodeling.” J Invest Surg 2012; 25: 330
3 Bryan N, Ahswin H, Smart NJ, Bayon Y, Hunt JA. “In vitro activation of human leukocytes in response to contact with synthetic hernia meshes.” Clin Biochem 2012; 45: 672
4 Aydinuraz K, Agalar C, Agalar F, Ceken S, Buruyurek N, Voral T. “In vitro S. epidermidis and S. aureus adherence to composite and lightweight polypropylene grafts.” J Surg Res 2009; 157: e79.
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 Klinge U, Junge B, Spellerberg B, Piroth C, Klosterhalfen B, Schumpelick V. “Do multifilament alloplastic meshes increase the infection rate? Analysis of the polymeric surface, the bacterial adherence, and the in vivo consequences in a rat model.” J Biomed Mater Res (Appl Biomater) 2002; (63): 765-771.
7 Long-term clinical data not yet available.

Tissue Incorporation

At 12 weeks, Phasix™ ST Mesh is well incorporated with new vascularized tissue and minimal inflammatory response. A new peritoneal layer has been laid down in place of the ST barrier. By 48 weeks, Phasix™ ST Mesh continues to be remodeled and is replaced with mature functional tissue.1


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

Ordering Information

    • 1200008
    • 1/cs.
    • Round 8 cm (3”)
    • 1200011
    • 1/cs.
    • Round 11 cm (4.5”)
    • 1200015
    • 1/cs.
    • Round 15 cm (6”)
    • 1200710
    • 1/cs.
    • Rectangle 7 cm x 10 cm (3” x 4”)
    • 1201010
    • 1/cs.
    • Square 10 cm x 10 cm (4” x 4”)
    • 1201015
    • 1/cs.
    • Rectangle 10 cm x 15 cm (4” x 6”)
    • 1201020
    • 1/cs.
    • Rectangle 10 cm x 20 cm (4” x 8”)
    • 1201325
    • 1/cs.
    • Rectangle 13 cm x 25 cm (5” x 10”)
    • 1201520
    • 1/cs.
    • Rectangle 15 cm x 20 cm (6” x 8”)
    • 1202025
    • 1/cs.
    • Rectangle 20 cm x 25 cm (8” x 10”)
    • 1202530
    • 1/cs.
    • Rectangle 25 cm x 30 cm (10” x 12”)
    • 1203035
    • 1/cs.
    • Rectangle 30 cm x 35 cm (12” x 14”)

Accessories

Indications
Phasix™ ST Mesh is indicated for use in the reinforcement of soft tissue, where weakness exists, in procedures involving soft tissue repair, such as for the repair of hernias.

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

Warnings
Device manufacture involves exposure to tetracycline hydrochloride and kanamycin sulfate. The safety and product use for patients with hypersensitivities to these antibiotics is unknown. Use of this device in patients with known allergies to tetracycline hydrochloride or kanamycin sulfate should be avoided.

Ensure proper orientation; the coated side of the prosthesis should be oriented against the bowel or sensitive organs. Do not place the uncoated mesh side against the bowel. There is a risk for adhesion formation or erosions when the uncoated mesh side is placed in direct contact with the bowel or viscera. (Reference Surface Orientation section of the instructions for use.)

The safety and effectiveness of Phasix ST Mesh in bridging repairs has not been evaluated or established.

The use of any synthetic mesh or patch in a contaminated or infected wound could lead to fistula formation and/or extrusion of the mesh and it is not recommended.

If an infection develops, treat the infection aggressively. Consideration should be given regarding the need to remove the mesh. An unresolved infection may require removal of the mesh.

The safety and effectiveness of Phasix™ ST Mesh in the following applications has not been evaluated or established: Pregnant women, Pediatric use, Neural and Cardiovascular tissue.

Precautions
The safety and effectiveness of the mesh has not been evaluated in the presence of malignancies in the abdominopelvic cavity.

Adverse Reactions
In preclinical testing, Phasix ST Mesh elicited a minimal tissue reaction characteristic of foreign body response to a substance. The tissue reaction resolved as the mesh was resorbed. Possible complications may include, but are not limited to, seroma, adhesion, hematoma, pain, infection, inflammation, allergic reaction, hemorrhage, extrusion, erosion, migration, fistula formation and recurrence of the hernia or soft tissue defect.

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

DAV/PHST/0915/0022