TELA Bio and Aroa Biosurgery have secured 510(k) clearance from the US Food and Drug Administration (USFDA) to market large sizes of OviTex Reinforced BioScaffolds (RBSs) for soft tissue repair.
Image: TELA Bio, Aroa Biosurgery secure 510(k) clearance from USFDA for OviTex RBSs. Photo: Courtesy of David Castillo Dominici/FreeDigitalPhotos.net.
TELA Bio has started commercialization for large size OviTex RBS for hernia repair and abdominal wall reconstruction.
The OviTex Permanent product line is now available for sale in the US from TELA Bio in sizes up to 25×40 cm (1,000 cm2). This is a 150% increase in surface area over currently available devices.
TELA Bio president and CEO Antony Koblish said: “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.
“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.”
OviTex RBSs are claimed to be the only devices that can reinforce biologic materials with polymer fibers in an embroidered construction allowing functional tissue remodeling and improved strength and handling.
OviTex is claimed to have been designed, in collaboration with surgeons to address an unmet clinical need in hernia repair. It is claimed to surpass the performance of existing hernia repair products.
The biologic material is derived from ovine rumen and is claimed to have been optimized to reduce foreign body response, minimize inflammation while enabling functional tissue remodeling.
The interwoven polymer can offer long-term strength, along with improved handling and load-sharing capability.
Aroa Biosurgery CEO Brian Ward said: “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. 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.”