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Phasix™ ST Mesh

Fully Bioresorbable Scaffold Featuring Proven Sepra® Technology

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Overview

Designed to enable functional tissue remodeling for a strong repair

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

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Features and Benefits

MATERIAL STRUCTURE1

Monofilament mesh designs have been deemed more biocompatible and less susceptible to bacterial adherence and colonization.1

The Next Phase in Hernia Repair

  • Repairs hernias1

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

  • Remodels issues over time1

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

  • Restores functional tissue.1

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

  • Versatile techniques

    Phasix™ ST Mesh may be placed in either an intraabdominal or preperitoneal position after primary hernia defect closure. Primary hernia defect closure should be achieved prior to placing the mesh.

  • Hernia defect closure

    Hernia defect closure can be achieved through an open or minimally invasive approach (i.e., laparoscopic, robotic). 

  • Promising results in the presence of bacteria 

    Phasix™  ST 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.

Reference

1. 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. RPT3807332.

2. DeMeester, Steven R, et al. Combination of surgical technique and bioresorbable mesh reinforcement of the crural repair leads to low early hernia recurrence rates with laparoscopic paraesophageal hernia repair. J Gastrointest Surg. 2020

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, including hiatal 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.)

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.

For hiatal hernia repair, the use of Phasix™ ST Mesh circumferentially around the esophagus is not recommended.

For hiatal hernia repair, the use of Phasix™ ST Mesh to bridge the hiatus is not recommended.

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 Phasix™ ST 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. Possible complications in hiatal hernia repair may include esophageal erosion and dysphagia related to crural fibrosis.

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

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BD-24260

Products & Accessories
  • product-image

    Phasix™ ST Mesh, Round, 8 cm (3 in)

  • product-image

    Phasix™ ST Mesh, Rectangle, 10 cm x 15 cm (4 in x 6 in)

  • product-image

    Phasix™ ST Mesh, Rectangle, 13 cm x 25 cm (5 in x 10 in)

  • product-image

    Phasix™ ST Mesh, Round, 15 cm (6 in)

  • product-image

    Phasix™ ST Mesh, Rectangle, 30 cm x 35 cm (12 in x 14 in)

  • product-image

    Phasix™ ST Mesh, Rectangle, 15 cm x 20 cm (6 in x 8 in)

  • product-image

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

  • product-image

    Phasix™ ST Mesh, Rectangle, 7 cm x 10 cm (3 in x 4 in)

  • product-image

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

  • product-image

    Phasix™ ST Mesh, Rectangle, 25 cm x 30 cm (10 in x 12 in)

  • product-image

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

  • product-image

    Phasix™ ST Mesh, Rectangle, 20 cm x 25 cm (8 in x 10 in)

Related Products

References

1. 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. RPT3807332.

2. DeMeester, Steven R, et al. Combination of surgical technique and bioresorbable mesh reinforcement of the crural repair leads to low early hernia recurrence rates with laparoscopic paraesophageal hernia repair. J Gastrointest Surg. 2020

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, including hiatal 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.)

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.

For hiatal hernia repair, the use of Phasix™ ST Mesh circumferentially around the esophagus is not recommended.

For hiatal hernia repair, the use of Phasix™ ST Mesh to bridge the hiatus is not recommended.

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 Phasix™ ST 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. Possible complications in hiatal hernia repair may include esophageal erosion and dysphagia related to crural fibrosis.

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

true
Resources
References

1. 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. RPT3807332.

2. DeMeester, Steven R, et al. Combination of surgical technique and bioresorbable mesh reinforcement of the crural repair leads to low early hernia recurrence rates with laparoscopic paraesophageal hernia repair. J Gastrointest Surg. 2020

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, including hiatal 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.)

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.

For hiatal hernia repair, the use of Phasix™ ST Mesh circumferentially around the esophagus is not recommended.

For hiatal hernia repair, the use of Phasix™ ST Mesh to bridge the hiatus is not recommended.

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 Phasix™ ST 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. Possible complications in hiatal hernia repair may include esophageal erosion and dysphagia related to crural fibrosis.

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

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