Aroa Biosurgery. 2 Kingsford Smith Place, Airport Oaks, Auckland 2022, New Zealand

S4M Europe. 59, rue Castellion. 01100 Oyonnax – France

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. OviTex IHR 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 inguinal hernias that require the use of reinforcing 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 a surgical mesh): pain, infection, dysphagia, hernia recurrence, dehiscence, abscess, 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, the TELA Bio logo, and OviTex® are registered trademarks of TELA Bio, Inc. All other trademarks are trademarks of their respective owners or holders.

References: 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. Reinpold W. Risk factors of chronic pain aer inguinal hernia repair: a systematic review. Innov Surg Sci, 2017; 2(2): 61–68. 7. Ferzoco SJ. Early experience outcome of a reinforced Bioscafold in inguinal hernia repair: A case series. Intl J Surg Open, 2018;12:9-11 8. 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 9. 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 10. 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 highest risk patients. Surgical endoscopy, 35(9), 5173–5178. https://doi.org/10.1007/s00464-020-08009-1. 11. 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. 12. 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. 13. 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. 14. 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

MK-PM-0123 (April 2025)