Stanford spin-out Fibralign announced that it received CE Mark approval in Europe for its BioBridge collagen matrix.
Union City, Calif.-based Fibralign’s BioBridge has been designated as a Class III device with an indication for use in supporting lymphatic tissue repair and can be used after or in conjunction with surgical procedures addressing lymphedema, according to a news release.
Made of highly purified collagen, BioBridge is a sterile, biocompatible and biodegradable surgical mesh created through Fibralign’s Nanoweave 3D scaffolding technology. It is already cleared by the FDA or use in the U.S. as a surgical mesh for reinforcing and repairing soft tissue, but it has not been approved in the states for treating lymphedema.
Fibralign additionally received an updated ISO 13485:2016 certification of its quality management system, it said in the release, demonstrating its capabilities in meeting the global International Standards Organization’s requirements for medical devices.
