Biorez announced that it received FDA 510(k) clearance for two sizes of its BioBrace implant for tendon and ligament procedures.
New Haven, Conn.-based Biorez designed its biocomposite soft tissue scaffold for use in a range of surgical procedures to reinforce soft tissue where weakness exists, according to a news release. The implant can be used with existing surgical techniques and instrumentation.
The implant design includes a highly porous collagen matrix and resorbable PLLA microfilaments, offering a bio-inductive scaffold with strength to reinforce tendon and ligament repairs while promoting healing, Biorez said.
Additionally, the implant is fully resorbable and naturally broken down by the body as a change of pace from historical implant materials, which have been either synthetic or biologic, limiting their use and effectiveness as augmentation materials in tendon and ligament repair.
“We expect BioBrace to be a game-changing technology for surgeons seeking to augment their repairs mechanically and biologically,” Biorez founder & CEO Kevin Rocco said in the release. “Our goal is to help patients return to full activity sooner, and potentially reduce re-injuries. We look forward to partnering with surgeons to demonstrate the clinical effectiveness of BioBrace for their patients.”