MALVERN, Pa., March 11, 2019 /PRNewswire/ -- TELA Bio®, Inc., a surgical reconstruction company leading the development and commercialization of OviTex® Reinforced BioScaffolds (RBSs) for soft tissue repair, today announced the presentation of results from three studies in patients treated with OviTex® RBSs at the American Hernia Society Annual Meeting being held March 11 – 14 at the Aria Hotel in Las Vegas, NV.
Samir S. Awad MD, MPH, FACS, professor of surgery at Baylor College of Medicine, will present findings from a study entitled "Resilience and Healing of a Novel Reinforced BioScaffold (RBS) Matrix in the Setting of High-Risk Incisional Hernia Repair After Enterocutaneous Fistula (ECF) Takedown." The study assesses the strength of RBS in a patient who developed a surgical site infection (SSI) after enterocutaneous fistula takedown with hernia repair. At 12 months post-op, results showed the mesh was resilient to infection and facilitated faster wound healing compared to other synthetic or biologic product options.
"Concurrent repairs like these are not traditionally treated with synthetic mesh and have been shown to result in a high risk of SSI," said Dr. Awad. "The fact that RBS seamlessly incorporated within the wound with rapid granulation is very encouraging and we look forward to further research that could lead to a better understanding of the benefits of this unique surgical mesh."
In a separate presentation titled "A Study of Mesh Compliance: Implications for Proper Splinting for Fascial Repair in Abdominal Wall Reconstruction," Howard Langstein, MD, chief of plastic and reconstructive surgery at the University of Rochester Medical Center, will detail results of a study evaluating the compliance or elasticity of OviTex RBS compared to PhasixTM resorbable mesh to determine the suitability of each to offload primary fascial repairs. Results demonstrate that OviTex RBS was less compliant and therefore potentially better engineered to protect the repair post-operatively.
"These results represent a new milestone into our understanding of the mechanism whereby synthetic or biologic mesh can reduce the risk of recurrence," said Langstein. "We are pleased to see that RBS was able to support the native compliance of the abdominal wall without negatively altering it and we look forward to evaluating performance related to compliance long-term."
In a third presentation titled "Ovine Polymer-Reinforced Bioscaffold in Abdominal Wall Reconstruction," Michael A.J. Sawyer, MD, FACS, with the department of surgery at Oklahoma State University, will present results on the use of ovine polymer-reinforced bioscaffold (OPRBS) in abdominal wall reconstruction (AWR). A review of patients who underwent AWR with myofascial advancement flap creation and augmentation with OPRBS (n=23) found recurrence and complication rates were low and patient satisfaction was high at follow up between nine-33 months.
"This study further emphasizes the inherent weaknesses of either biologic and synthetic mesh to deliver both durability and comfort while reducing the risk of recurrence." Dr. Sawyer continued, "This analysis highlights the potential benefits of a repair mesh that incorporates both biologic and synthetic materials, which could lead to an improvement in clinical outcomes long-term."
About TELA Bio, Inc.
TELA Bio, Inc. is a privately-owned company focused on bringing innovative, cost-effective, surgical reconstruction solutions to surgeons, hospitals and patients. The company's OviTex Reinforced BioScaffolds (RBSs) products, designed for hernia repair and abdominal wall reconstruction procedures, integrate polymer and biologic materials in a uniquely embroidered construction using novel engineering design principles. The OviTex portfolio is supported by high-quality, data-driven science and extensive pre-clinical research that has consistently demonstrated the advantages of an RBS over commercially available products. OviTex RBSs are commercially available in the U.S. and in Europe. The company is collaborating with leading surgeons to drive rapid product development and establish TELA Bio as a leader in surgical reconstruction. To learn more about TELA Bio visit http://www.telabio.com.
About OviTex Reinforced BioScaffolds
OviTex Reinforced BioScaffolds (RBSs) are 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.
Do not use OviTex RBSs in patients known to be sensitive to materials of ovine (sheep) origin. For additional important safety information, please see the OviTex RBSs Instructions for Use.
The statements made or results achieved by TELA Bio customers described herein were achieved in their specific setting. Due to variations in clinical experience and technique, there is no guarantee that these results are typical. Bench testing may not be indicative of clinical performance.
Caution: Federal (US) law restricts this device to sale by or on order of a physician.
TELA Bio, Inc. owns or has applied for the following trademarks or service marks: OviTex, TELA Bio. All other trademarks are trademarks of their respective owners or holders.
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