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.
- 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.
- 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.
- Data on File (PD-STU-0011).
- TELA Bio sales data.
- 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.
- Data on File (RE-STU-0024-R).
- 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.
- 2021 MedSKU Data.
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.