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Medtronic / Covidien Products / Hernia Repair / Transorb™ Self-Gripping Resorbable Mesh

Overview

Transorb™ self-gripping resorbable mesh for open extraperitoneal ventral hernia repair

Transorb™ mesh is designed to provide the robust reinforcement your patients need throughout the critical healing period — and then fully resorb.

Superior strength†,1,2
  • Stronger mesh: a significantly higher tensile strength than Phasix™* mesh‡,1
  • Stronger attachment: attachment force to the tissue is 1.6 times stronger§,◊,2 with ProGrip™ technology
  • Stronger repair: macroporosity allows for excellent tissue ingrowth, providing mechanical strength to the defect repair◊,2–5
Repairs. Reinforces. Resorbs.◊,2–6
  • Tissue integration: resorbable microgrips support excellent tissue integration◊,2,7
  • Critical healing period: provides the same support as a permanent synthetic mesh during the critical healing period, while gradually resorbing into the body over time◊,¶,2,6
  • Pore size matters: large pores are associated with a reduced risk of infection and shrinkage,2,3,8 as well as reduced seroma formation◊,2,9

Innovation in hernia repair

Familiarize yourself with the one-of-a-kind benefits of Transorb™ self-gripping resorbable mesh.

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See how Transorb™ self-gripping resorbable mesh is designed to deliver a fully resorbable repair.

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Order Information

ORDER CODE DESCRIPTION DIMENSIONS QUANTITY
TSB1510 Transorb™ self-gripping resorbable mesh, poly-L-lactide, poly-trimethylene carbonate (PLLA/TMC) copolymers with grips on one side 15 cm × 10 cm
(5.9 in × 3.9 in)		 1 per box
TSB2020 Transorb™ self-gripping resorbable mesh, poly-L-lactide, poly-trimethylene carbonate (PLLA/TMC) copolymers with grips on one side 20 cm × 20 cm
(7.9 in × 7.9 in)		 1 per box
TSB3030 Transorb™ self-gripping resorbable mesh, poly-L-lactide, poly-trimethylene carbonate (PLLA/TMC) copolymers with grips on one side 30 cm × 30 cm
(11.8 in × 11.8 in)		 1 per box
TSB4030 Transorb™ self-gripping resorbable mesh, poly-L-lactide, poly-trimethylene carbonate (PLLA/TMC) copolymers with grips on one side 40 cm × 30 cm
(15.7 in × 11.8 in)		 1 per box

Order Information

Specifications

Materials Poly-L-lactide, poly-trimethylene carbonate copolymer (PLLA/TMC) with grips on one side10
Resorption Mesh degradation by hydrolysis is nearly complete in 18–24 months, with remaining fibers essentially resorbed in 36–60 months. The total resorption period depends on numerous factors, including unique patient physiology.◊,2,6
Pore size Large pore
(1.4 mm × 1.4 mm)#,2
ProGrip™ technology Grips are present over the entire mesh surface to help maintain the device in place during abdominal wall closure11,12 and may limit the need for additional fixation◊,13

Frequently asked questions

What are the indications for use?
Transorb™ self-gripping resorbable mesh is intended to be used for the reinforcement of abdominal wall soft tissues where weakness exists in open procedures involving ventral hernia repair.

Where is Transorb™ mesh designed to be used?
Transorb™ self-gripping resorbable mesh is designed for ventral hernia repair when placed in an extraperitoneal space by open surgical approach. The compatibility of Transorb™ mesh with trocars and laparoscopic instruments has not been established. Transorb™ mesh is not recommended for passage through a trocar.

How long does Transorb™ mesh take to resorb?
At eighteen to twenty four months, mesh degradation is nearly complete. The remaining mesh fibers are essentially resorbed in thirty six to sixty months post-implantation. The total resorption period depends on numerous factors, including unique patient physiology.◊,2,6

How long does Transorb™ mesh provide abdominal wall reinforcement?
Preclinical studies showed that the mesh maintains mechanical characteristics to reinforce the abdominal wall in vivo for at least twenty weeks and progressively resorbs.◊,¶,2,6

How long do the grips contribute to mesh fixation?
Preclinical studies showed that the grips contribute to the fixation of the mesh to surrounding tissue in vivo for at least four weeks.◊,13

What is the shelf life of Transorb™ mesh?
Three years.

Risk statement

Mesh complications may include but are not limited to hematoma, seroma, infection, acute and chronic pain, extrusion/erosion, inflammation, recurrence.

  • The use of any synthetic mesh in a contaminated or infected site could lead to additional complications 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 placement of Transorb™ self-gripping resorbable mesh as a bridging device is not recommended. When using Transorb™ self-gripping resorbable mesh, the defect shall be closed.
  • The use of additional suture fixation is recommended to limit the risk of hernia recurrence.
  • When implanting in a pre-peritoneal site; the mesh shall not be placed with the grips toward the peritoneum, adhesion may develop if grips are in contact with bowels. The self-gripping side of the mesh can be differentiated from the smooth non-gripping side visually or through tactile feel.
  • When implanting in a preperitoneal site, complete coverage of the mesh with peritoneum should be achieved to minimize the risks of adhesion.
  • The compatibility of Transorb™ self-gripping resorbable mesh with trocars and laparoscopic instruments has not been established. Transorb™ self-gripping resorbable mesh is not recommended for passage through a trocar; product damage may occur.

Please refer to instructions for use for complete contraindications and risk information.

Resources

  • TM* Third-party brands are trademarks of their respective owners.

  • † Compared to ProGrip™ self-gripping polyester mesh and Phasix™* mesh. Compared to a flat sheet mesh with the same level of suture fixation. Based on preclinical testing and benchtop studies, not necessarily indicative of human clinical outcomes.

  • ‡ Based on benchtop studies, not necessarily indicative of human clinical outcomes.

  • § Compared to a flat sheet mesh with the same level of suture fixation.

  • ◊ Based on preclinical testing, not necessarily indicative of human clinical outcomes.

  • ¶ Compared to ProGrip™ self-gripping polyester mesh in simulated in vitro conditions at 20 weeks.

  • # These are mean values measured from one batch, which may vary slightly within and between batches depending on the testing method used.

  • 1. Based on internal report 1203CR764a, Phasix™* mesh versus Transorb™ self-gripping resorbable mesh — ball burst statistical comparison. October 2021.

  • 2. Vestberg R, Lecuivre J, Radlovic A, Payet E, Bayon Y, Bouré L. A novel self-gripping long-term resorbable mesh providing temporary support for open primary ventral and incisional hernia. J Mater Sci Mater Med. 2023;34(11):59.

  • 3. Brown CN, Finch JG. Which mesh for hernia repair? Ann R Coll Surg Engl. 2010;92(4):272–278.

  • 4. Lake SP, Ray S, Zihni AM, Thompson DM Jr, Gluckstein J, Deeken CR. Pore size and pore shape — but not mesh density — alter the mechanical strength of tissue ingrowth and host tissue response to synthetic mesh materials in a porcine model of ventral hernia repair. J Mech Behav Biomed Mater. 2015;42:186–197.

  • 5. Weyhe D, Cobb W, Lecuivre J, et al. Large pore size and controlled mesh elongation are relevant predictors for mesh integration quality and low shrinkage — Systematic analysis of key parameters of meshes in a novel minipig hernia model. Int J Surg. 2015;22:46–53.

  • 6. Based on internal report 1203CR462a, Evaluation of Transorb™ self-gripping resorbable mesh and Deternia™ self-gripping resorbable mesh degradation and associated local tissue effects. November 2023.

  • 7. Based on internal report BIO111-a, Biological evaluation report: Transorb™ self-gripping resorbable mesh and Deternia™ self-gripping resorbable mesh. October 1, 2021.

  • 8. Weyhe D, Belyaev O, Müller C, et al. Improving outcomes in hernia repair by the use of light meshes — a comparison of different implant constructions based on a critical appraisal of the literature. World J Surg. 2007;31(1):234–244.

  • 9. Jin J, Schomisch S, Rosen MJ. In vitro evaluation of the permeability of prosthetic meshes as the possible cause of postoperative seroma formation. Surg Innov. 2009;16(2):129–133.

  • 10. Transorb™ self-gripping resorbable mesh instructions for use. Trévoux, France: Medtronic; 2023.

  • 11. Based on internal report 1203CR621a, Design verification activities associated with DI-261 (ex vivo gripping test without fixation). November 2020.

  • 12. Based on internal report 1203CR752a, Design validation and summative usability evaluation of Transorb™ self-gripping resorbable mesh — additional study. October 2021.

  • 13. Based on internal report 1203CR867, Evaluation and comparison of meshes fixation strengths in a porcine model at four weeks after implantation: pivotal study. November 2023.

  • 14. Based on internal report 1203CR709, Comparison of abdominal hernia meshes evaluated in a porcine ventral abdominal wall defect model: pivotal study. November 2023.

  • 15. Based on internal report 1203CR510a, Memorandum: degradation mechanism of resorbable mesh. June 2020.

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