TELA Bio®, Inc. and Aroa Biosurgery, the joint developers of OviTex® Reinforced BioScaffolds (RBSs) for soft tissue repair, today announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market large sizes of OviTex RBS. The OviTex Permanent product line is now commercially available in United States from TELA Bio in sizes up to 25x40 cm (1,000 cm²), which is a 150% surface area increase over currently available devices.

"We are pleased to launch larger OviTex RBSs as we continue our mission to provide valuable solutions for a full range of hernia repairs and abdominal wall reconstructions, including the most complex cases," said Antony Koblish, president and CEO of TELA Bio. "Traditionally, large abdominal wall hernias can present a technical challenge for some surgeons. Our devices are now positioned to ensure that patients who are most at need have access to the most advanced technology to assist with their hernia repair." 

A distinct class of surgical mesh, OviTex RBSs is the only devices available that reinforce biologic materials with polymer fibers in a unique embroidered construction that allows for functional tissue remodeling, as well as improved strength and handling.

"The ability to cover a larger surface area could have many potential benefits for patients and surgeons in terms of securing the most complex hernia repairs properly and reducing the risk of recurrence," said Brian Ward, CEO of Aroa Biosurgery. "As a joint developer and the manufacturer of the Ovitex technology, it is encouraging to see growing demand and the continued expansion of our product portfolio. We provide a robust and comprehensive suite of accessible and affordable options that address the current shortcomings in surgical hernia repair solutions."