IlluminOss Medical Granted FDA Marketing Clearance for the IlluminOss® Bone Stabilization System (press release)
IlluminOss Medical, a privately held, commercial-stage medical device company focused on minimally invasive orthopedic fracture repair, today announced that it has received U.S. Food and Drug Administration (FDA) de novo clearance for the IlluminOss Bone Stabilization System for treatment of impending and actual pathological fractures of the humerus, radius and ulna from metastatic bone disease.
The IlluminOss System incorporates the use of a thin-walled PET balloon that is infused with a liquid monomer and delivered in a minimally invasive fashion into the intramedullary canal of the bone through a small incision.
Once the balloon is infused with monomer, it conforms to the shape of the patient’s specific bone. The surgeon then activates a light source which delivers visible light to the PET balloon, polymerizing the monomer. The cured, hardened implant provides longitudinal strength and rotational stability over the length of the implant, stabilizing the fracture.
The IlluminOss System, which has been commercially available in international markets and been in clinical...
