www.fdanews.com/articles/189867-tela-aroa-receive-fda-clearance-for-bioscaffolds
Tela, Aroa Receive FDA Clearance for Bioscaffolds
January 14, 2019
The FDA granted Tela Bio and Aroa Biosurgery a 510(k) clearance for their large-size OviTex bioscaffolds.
The reinforced bioscaffold is a surgical implant used by surgeons for hernia repair. The implant has both a textured side to stimulate tissue growth and a smooth side that minimizes tissue attachment.
The device is made up of biologic and synthetic materials, allowing the movement of cells and fluids through the product.