TELA Bio to Present Surgeon Feedback from Initial Clinical Experience with OviTex™ Reinforced BioScaffolds and Product Permeability Data at Abdominal Wall Reconstruction Conference
Surgeons experience clinical success with OviTex products in a wide range of hernia patients
MALVERN, Pa., June 5, 2017 /PRNewswire/ — TELA Bio, Inc., a surgical reconstruction company leading the development of OviTex™ Reinforced BioScaffolds (RBSs) for soft tissue repair, today announced the company will present at the MedStar Georgetown University Hospital’s Abdominal Wall Reconstruction (AWR) Conference being held June 8-10 at the JW Marriott in Washington, D.C.
OviTex RBSs are implants for hernia repair and abdominal wall reconstruction. They were purposefully designed to integrate biologic material and polymer in a unique embroidered construction which allows free movement of fluid and cells through the construct.
Maarten Persenaire, MD, chief medical officer of TELA Bio, will present surgeon feedback on initial clinical experience with OviTex RBSs in hernia patients since receiving U.S. Food and Drug Administration (FDA) 510(k) clearance in June 2016. Surgeons observed 134 patients treated with OviTex RBSs and provided feedback for 128 patients after an average follow-up of 108 days. No device failures or hernia recurrences were reported.
“OviTex RBSs have now been successfully used in a wide range of hernia repair procedures,” said Dr. Persenaire. “Surgeons are noting that OviTex RBSs are easy to handle, trim, suture, and tack in all surgical approaches, and conform well to contours of surgical sites. We are also encouraged by surgeon reports of reduced volume and duration of drainage post-operatively. This gives us confidence for our prospective multi-center ventral hernia BRAVO study which started enrollment this April.”
In a separate presentation, Skott Greenhalgh, PhD, chief technology officer of TELA Bio, and Stephen Ferzoco, MD, FACS, Boston-based hernia surgeon, will present results from a preclinical study evaluating the permeability of various hernia repair materials including the company’s OviTex RBSs. The study results showed OviTex RBSs exhibited permeability in contrast to market-leading biologic materials and coated synthetic meshes.
“Little attention has been paid to the permeability of hernia repair materials and the role permeability plays in their clinical performance,” said Dr. Greenhalgh. “We believe it is important that OviTex RBSs exhibit permeability, as this may reduce the incidence of post-operative complications, including seromas. Furthermore, permeable implants could enhance tissue integration and remodeling through free movement of fluid and cells, which are critical to long-term durability of the repair.”
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 TELA Bio plans to launch OviTex RBSs in the European Union. 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.
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SOURCE TELA Bio, Inc.
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