Tela Bio said yesterday that it won FDA 510(k) clearance for its Restella reconstructive bioscaffolds, now cleared for use in reinforcing soft tissue in patients requiring soft tissue repair or reinforcement during plastic or reconstructive procedures.
The Malvern, Penn.-based company’s tech platform is based on interwoven polymer through layers of biologic tissue in a patented pattern that it claims creates a unique, embroidered construction. The biological material is derived from ovine rumen, the company said, and is intended to reduce foreign body response, minimize inflammation and enable functional tissue remodeling.
“We are excited to bring Restella Reconstructive BioScaffolds to U.S. surgeons and patients. These products were purposefully engineered to allow for rapid tissue integration and revascularization and biomechanical control. Specifically designed for use in reconstructive surgery, Restella products leverage the strong clinical experience of our OviTex Reinforced BioScaffolds that have now been implanted in more than 4,500 patients. Our success in applying the advantages of our technology platform to develop Restella Reconstructive BioScaffolds is another example of TELA Bio’s unique ability to bring innovation and cost savings to address a wide range of needs in surgery. By expanding our platform to more surgeons and patients, we are bringing the same level of innovation and cost savings to the reconstructive surgery market that we have delivered with OviTex Reinforced BioScaffolds in hernia repair procedures,” prez & CEO Antony Koblish said in a press release.
In January, Tela Bio and its partner Aroa Biosurgery said that they won FDA 510(k) clearance for large-size OviTex reinforced bioscaffolds intended for soft tissue repair.