OviTex Reinforced BioScaffolds

Two Studies Evaluate OviTex Reinforced BioScaffolds for Hernia and Soft Tissue Repair

MedicalResearch.com Interview with:

Maarten Persenaire, MD Co-founder, Chief Medical Officer TELA Bio

Dr. Persenaire

Maarten Persenaire, MD
Co-founder, Chief Medical Officer
TELA Bio

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: OviTex Reinforced BioScaffolds (RBSs) are a novel distinct class of surgical implants that combine biologic and synthetic materials in a unique embroidered construction and design for hernia repair and soft tissue reconstruction. The two recent publications reported clinical results of OviTex RBS performance in inguinal and hiatal hernia repair.

Case series published in the International Journal of Surgery Open evaluated the role of OviTex RBSs in inguinal hernia repair to reduce the incidence of chronic postoperative pain. Thirty-one consecutive patients who had inguinal hernia repaired with OviTex RBSs were followed for an average of 12.6 months, during which time there were no reported recurrences, complications requiring surgical intervention or infections. None of the patients reported postoperative inguinal pain beyond the first days after surgery and none required a narcotic pain medication refill.

The second study published in the Journal of the Society of Laparoendoscopic Surgeons is the first reported series describing the use of OviTex RBSs in hiatal hernia repair. A retrospective chart review of 25 consecutive patients undergoing laparoscopic or open hiatal hernia repairs with mean follow-up of 14.2 months showed no recurrences. The hiatal hernia repairs with OviTex RBSs resulted in good to excellent control and resolution of symptoms, including heartburn, dysphagia, regurgitation, nausea and vomiting, dyspnea, and chest pain or discomfort. 

OviTex Reinforced BioScaffolds

OviTex Reinforced BioScaffolds

MedicalResearch.com: What should readers take away from your report?

Response: The results of the two recent publications are encouraging, demonstrating that OviTex RBSs provide for easy to execute repairs that result in effective symptom control and potential benefits in pain management. With growing media focus on complications resulting from soft tissue repairs with synthetic mesh, OviTex RBSs may offer a unique solution. OviTex RBSs, because of their distinct composition and construction, have been shown in animal studies to minimize the inflammatory response associated with synthetic mesh and thus provide a more natural repair. Longer term follow-up and additional studies in more patients are conducted to confirm these findings.

MedicalResearch.com: What recommendations do you have for future research as a result of this work?

Response: It is important to continue evaluating OviTex RBS performance in various types of hernias, in addition to inguinal and hiatal. Longitudinal, multi-center studies, in representative samples of patients, are necessary to confirm the early positive findings presented in these publications. The importance of creating the right balance between durable reinforcement and a natural repair with minimal inflammatory response is increasingly recognized. We believe that OviTex RBSs come closer to achieving this balance and can provide measurable benefits to patients with different types of hernias as well as in other soft tissue repairs. It is also important to continue to increase our understanding  of the causal, not just associative, relationship between hernia repair materials, symptom resolution, inflammatory response, and pain. Lastly, a better understanding and control of the mechanical factors that influence healing, remodeling and ultimately the final function of the repaired tissue is desirable.

MedicalResearch.com: Is there anything else you would like to add?

Response: Our unique manufacturing techniques make it easier to make modifications to existing products than for other materials. We welcome input from surgeons to continue improving the design of our products with the goal to further optimize healing, handling and the clinical outcomes for patients.

Citation:

Early experience outcome of a reinforced Bioscaffold in inguinal hernia repair: A case series
Stephen J.Ferzoco
International Journal of Surgery Open
Volume 12, 2018, Pages 9-11

 

Sep 24, 2018 @ 7:27 pm

 

 

 

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