References

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Abdominal Wall and Hernia Repair

Hernia Repair Clinical Data

Plastic & Reconstructive, Including Comparison

Internal Adhesives

Patients

*Animal test results may not always accurately predict the clinical performance or response in humans

1. Overbeck, N.; Nagvajara, G.M.; Ferzoco, S.; May, B.C.H.; Beierschmitt, A.; Qi, S. In-vivo evaluation of a reinforced ovine biologic: A comparative study to available hernia mesh repair materials. Hernia 2020, 24, 1293–1306.
2. Overbeck N, Beierschmitt A, May BCH, Qi S, Koch J. In-vivo evaluation of a reinforced ovine biologic for plastic and reconstructive procedures in a non-human primate model of soft tissue repair. ePlasty. 2022;22:e43.
3. Data on file

1. Overbeck, N.; Nagvajara, G.M.; Ferzoco, S.; May, B.C.H.; Beierschmitt, A.; Qi, S. In-vivo evaluation of a reinforced ovine biologic: A comparative study to available hernia mesh repair materials. Hernia 2020, 24, 1293–1306.
2. Lun S, Irvine S.M., Johnson K.D., Fisher N.J., Floden E.W., Negron L., Dempsey S.G., McLaughlin R.J., Vasudevamurthy M., Ward B.R., May B.C., A functional extracellular matrix biomaterial derived from ovine forestomach, Biomaterials 31(16) (2010) 4517-29.
3. Irvine, S. M.; Cayzer, J.; Todd, E. M.; Lun, S.; Floden, E. W.; Negron, L.; Fisher, J. N.; Dempsey, S. G.; Alexander, A.; Hill, M.C.; O’Rouke, A.; Gunningham, S. P.; Knight, C.; Davis, P. F.; Ward, B.R.; May, B. C. H. Quantification of in vitro and in vivo angiogenesis stimulated by ovine forestomach matrix biomaterial. Biomaterials 2011, 32 (27), 6351−61.
4. Dempsey SG, Miller CH, Hill RC, Hansen KC, May BCH. Functional Insights from the Proteomic Inventory of Ovine Forestomach Matrix. J Proteome Res. 2019 Apr 5;18(4):1657-1668. doi: 10.1021/acs.jproteome.8b00908. Epub 2019 Mar 25. PMID: 30879303.
5. Data on file.
6. Fernandez, Luis. Definitive ClosureUsing an Ovine Reinforced Tissue Matrix in the Complex Open Abdomen after Penetrating Thoraco-Abdominal Trauma. Poster Presented at: Abdominal Wall Reconstruction Conference; June 8-11, 2022; Virtual.
7. Goetz, M., Jurczyk, M., Junger, H., Schlitt, H. J., Brunner, S. M., & Brennfleck, F. W. (2022). Semiresorbable biologic hybrid meshes for ventral abdominal hernia repair in potentially contaminated settings: lower risk of recurrence. Updates in surgery, 74(6), 1995–2001. https://doi.org/10.1007/s13304-022-01378-3.
8. 2022 Q4 MedSku Data.
9. Ankney C, Banaschak C, Sowers B, Szotek P. Minimizing Retained Foreign Body in Hernia Repair Using a Novel Technique: Reinforced Biologic Augmented Repair (ReBAR). J Clin Med Res. 2021;3(4):1-11. https://doi.org/10.37191/Mapsci-2582-4333-3(4)-073 .
10. Sivaraj, D., Fischer, K. S., Kim, T. S., Chen, K., Tigchelaar, S. S., Trotsyuk, A. A., Gurtner, G. C., Lee, G. K., Henn, D., & Nazerali, R. S. (2022).Outcomes of Biosynthetic and Synthetic Mesh in Ventral Hernia Repair. Plastic and reconstructive surgery. Global open, 10(12), e4707. https://doi.org/10.1097/GOX.0000000000004707
11. Parker, M. J., Kim, R. C., Barrio, M., Socas, J., Reed, L. R., Nakeeb, A., House, M. G., & Ceppa, E. P. (2021). A novel biosynthetic scaffold mesh reinforcement affords the lowest hernia recurrence in the highestrisk patients. Surgical endoscopy, 35(9), 5173–5178. https://doi.org/10.1007/s00464-020-08009-1.
12. DeNoto, G., III, Ceppa, E. P., Pacella, S. J., Sawyer, M., Slayden, G., Takata, M., Tuma, G., & Yunis, J. (2022). 24-Month Results of the BRAVO Study: A prospective, multi-center study evaluating the clinical outcomes of a ventral hernia cohort treated with OviTex 1S Permanent Reinforced Tissue Matrix. Annals of Medicine and Surgery, 2022, 104745, ISSN 2049-0801. https://doi.org/10.1016/j.amsu.2022.104745.
13. Sivaraj, D., Henn, D., Fischer, K. S., Kim, T. S., Black, C. K., Lin, J. Q., Barrera, J. A., Leeolou, M. C., Makarewicz, N. S., Chen, K., Perrault, D. P., Gurtner, G. C., Lee, G. K., & Nazerali, R. (2022). Reinforced Biologic Mesh Reduces Postoperative Complications Compared to Biologic Mesh after Ventral Hernia Repair. Plastic and reconstructive surgery. Global open, 10(2), e4083. https://doi.org/10.1097/GOX.0000000000004083.
14. Sawyer M. (2018). New Ovine Polymer-Reinforced Bioscaffold in Hiatal Hernia Repair. JSLS : Journal of the Society of Laparoendoscopic Surgeons, 22(4), e2018.00057. https://doi.org/10.4293/JSLS.2018.00057
15. DeNoto, G., III (2022). Bridged repair of large ventral hernia defects using an ovine reinforced biologic: A case series. Annals of medicine and surgery (2012), 75, 103446. https://doi.org/10.1016/j.amsu.2022.103446.
16. Ferzoco, S. (2018). Early Experience outcome of a reinforced Bioscaffold in inguinal hernia repair: A case series. International Journal of Surgery Open, 12. 9-11. https://doi.org/10.1016/j.ijso.2018.06.001.

Disclaimers:
Indications and Important Safety Information: OviTex Reinforced Tissue Matrix is intended for use as a surgical mesh to reinforce and/or repair soft tissue where weakness exists.
Indications for use include the repair of hernias and/or abdominal wall defects that require the use of reinforcing or bridging material to obtain the desired surgical outcome.
Caution: Federal (US) law restricts this device to sale by or on order of a physician.
Do not use OviTex in patients known to be sensitive to materials of ovine (sheep) origin. Use of OviTex in this patient population may result in an allergic or immunological reaction.
The following adverse events have been reported for surgical repair of hernias (with or without the use of surgical mesh): pain, infection, hernia recurrence, adhesion, bowel obstruction, bleeding, fistula, seroma, perforation, mesh migration, and mesh contraction. For additional important safety information, please see the OviTex Instructions for Use. Healthcare professionals must use their own clinical judgment in evaluating appropriate treatment options for a particular patient. Treatment of a specific patient should be based on individual needs and the medical care deemed necessary by the patient’s treating physician and institutional protocols. Always refer to the package insert, product label, and/or instructions for use before using any TELA Bio product. Products may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual markets. Please contact your TELA Bio representative if you have questions about TELA Bio products. TELA Bio and OviTex are registered trademarks of TELA Bio, Inc. All other trademarks are trademarks of their respective owners or holders.

1. Sivaraj, D, Henn, D, Fischer, KS, Trudy S. Kim, TS, Black, CK, Lin, JQ, Barrera, JA, Leeolou, MC, Makarewicz, NS, Chen, K, Perrault, DP, Gurtner, GC, Lee, GK, Nazerali, R Reinforced Biologic Mesh Reduces Postoperative Complications Compared to Biologic Mesh after Ventral Hernia Repair: Plast Reconstr Surg Glob Open 2022;10:e4083; doi: 10.1097/GOX.0000000000004083

2. Ankney C, Banaschak C, Sowers B, Szotek P (2021) Minimizing Retained Foreign Body in Hernia Repair Using a Novel Technique: Reinforced Biologic Augmented Repair (ReBAR). Maples. 2021 July

3. Parker MJ, Kim RC, Barrio M, Socas J, Reed LR, Nakeeb A, House MG, Ceppa EP (2021) A novel biosynthetic scaffold mesh reinforcement affords the lowest hernia recurrence in the highest-risk patients. Surg Endosc. 2021 Sep;35(9): 5173-5178. doi: 10.1007/s00464-020-08009-1. Epub 2020 Sep 24. PMID: 32970208.

4. DeNoto,G III, Ceppa, EP, PacellaSJ, Sawyer, M, Slayden, G, Takata, M, Tuma, G, Yunis, J. 24 Month Results of the BRAVO Study: A prospective, multi-center study evaluating the clinical outcomes of ventral hernias treated with OviTex® 1S Permanent Re-inforced Tissue Matrix. American Hernia Society Annual Meeting Podium Presentation. September 14-16, 2022.

5. Overbeck et al, 2020 Hernia (Overbeck, N., Nagvajara, G.M., Ferzoco, S. et al. In-vivo evaluation of a reinforced ovine biologic: a comparative study to available hernia mesh repair materials. Hernia 24, 1293–1306 (2020). https://doi.org/10.1007/s10029-019-02119-z)

Healthcare professionals must use their own clinical judgment in evaluating appropriate treatment options for a particular patient.  Treatment of a specific patient should be based on individual needs and the medical care deemed necessary by the patient’s treating physician.  Always refer to the package insert, product label, and/or instructions for use before using any TELA Bio product. Products may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual markets. Please contact your TELA Bio representative if you have questions about TELA Bio products.

For Prescription Use Only. TELA Bio, Inc. owns or has applied for the following trademarks or service marks: TELA Bio, OviTex. All other trademarks are trademarks of their respective owners or holders.

OviTex is intended for use as a surgical mesh to reinforce and/or repair soft tissue where weakness exists. Indications for use include the repair of hernias and/or abdominal wall defects that require the use of reinforcing or bridging material to obtain the desired surgical outcome.

Caution: Federal law restricts this device to sale by or on the order of a physician.

Do not use TELA Bio devices in patients known to be sensitive to materials of ovine (sheep) origin. Use of OviTex in this patient population may result in an allergic or immunological reaction. For additional important safety information, please see the Instructions for Use. The following adverse events have been reported for surgical repair of hernias (with or without the use of surgical mesh): pain, infection, hernia recurrence, adhesion, bowel obstruction, bleeding, fistula, seroma, perforation, mesh migration, and mesh contraction.

  1. Overbeck N, Beierschmitt A, May BCH, Qi S, Koch J. In-vivo evaluation of a reinforced ovine biologic for plastic and reconstructive procedures in a non-human primate model of soft tissue repair. ePlasty. 2022;22:e43.
  2. Lun S, Irvine S.M., Johnson K.D., Fisher N.J., Floden E.W., Negron L., Dempsey S.G. , McLaughlin R.J., Vasudevamurthy M. , Ward B.R., May B.C., A functional extracellular matrix biomaterial derived from ovine forestomach, Biomaterials 31(16) (2010) 4517-29.
  3. Data on File (PD-STU-0011).
  4. TELA Bio sales data.
  5. Irvine, S. M.; Cayzer, J.; Todd, E. M.; Lun, S.; Floden, E. W.; Negron, L.; Fisher, J. N.; Dempsey, S. G.; Alexander, A.; Hill, M. C.; O’Rouke, A.; Gunningham, S. P.; Knight, C.; Davis, P. F.; Ward, B.R.; May, B. C. H. Quantification of in vitro and in vivo angiogenesis stimulated by ovine forestomach matrix biomaterial. Biomaterials 2011, 32 (27), 6351−61.
  6. Data on File (RE-STU-0024-R).
  7. Rademakers T, Horvath JM, van Blitterswijk CA, LaPointe VLS. Oxygen and nutrient delivery in tissue engineering: Approaches to graft vascularization. J Tissue Eng Regen Med. 2019 Oct;13(10):1815-1829. doi: 10.1002/term.2932. Epub 2019 Jul 30. PMID: 31310055; PMCID: PMC6852121.
  8. 2021 MedSKU Data.

Disclaimers:

Indications and Important Safety Information: OviTex PRS Reinforced Tissue Matrix is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use. Do not use OviTex PRS in patients with a known sensitivity to materials of ovine (sheep) origin. Use of OviTex PRS in this patient population may result in an allergic or immunological reaction. OviTex PRS is not intended for high load applications (e.g. bridging hernias, etc.). OviTex PRS has not been tested in breast surgical procedures.

Possible adverse events with the use of a soft tissue reinforcement device or any soft tissue reinforcement surgical procedure may include: additional intervention including surgery, adhesions, allergic reaction, bowel obstruction or perforation, bleeding, bruising, defect recurrence, dysphagia, erosion or extrusion, exposure or protrusion, fever, fistula, GERD, recurrence, infection, irritation or inflammation, pain, seroma or hematoma, swelling, and wound dehiscence. For additional important safety information, please see the OviTex PRS Instructions for Use. Healthcare professionals must use their own clinical judgment in evaluating appropriate treatment options for a particular patient. Treatment of a specific patient should be based on individual needs and the medical care deemed necessary by the patient’s treating physician. Always refer to the package insert, product label, and/or instructions for use before using any TELA Bio product. Products may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual markets. Please contact your TELA Bio representative if you have questions about TELA Bio products.

Caution: Federal (US) law restricts this device to sale by or on order of a physician.

OviTex and TELA Bio are registered trademarks of TELA Bio, Inc. All other trademarks and trade names are the property of their respective owners or holders.

  1. Indicated for polypropylene and polyester mesh in the US
  2. Based on laparoscopic studies
  1. Madsen LJ, Oma E, Jorgensen LN, Jensen KK. Mesh versus suture in elective repair of umbilical hernia: systematic review and meta-analysis. BJS Open. 2020 Jun;4(3):369-379. doi: 10.1002/bjs5.50276. Epub 2020 Apr 6. PMID: 32250556; PMCID: PMC7260408.