IlluminOss Medical minimally invasive fracture stabilization system gains FDA de novo clearance
IlluminOss Medical announced that it has received the FDA orthopedic branch’s first ever de novo clearance for its IlluminOss Bone Stabilization System, which is a novel treatment for impending and actual pathological fractures of the humerus, radius and ulna from metastatic bone disease.
The IlluminOss System conforms to the shape of the patient’s specific bone using a thin-walled polyethylene terephthalate (PET) balloon infused with a liquid monomer and delivered in a minimally invasive fashion into the bone’s intramedullary canal through a small incision, according to a company press release. The release noted a light source delivers visible light to the PET balloon to polymerize the monomer, and the cured, hardened implant provides longitudinal strength and rotational stability over the length of the implant to stabilize the fracture.
The IlluminOss System, which has been commercially available in international markets, been in clinical use since 2010. Commercialization efforts will begin in the US in the second quarter of 2018, according to the release
“The FDA marketing clearance marks a significant milestone for IlluminOss Medical, allowing us to bring our products to the US market,” Robert Rabiner, chief technology officer of IlluminOss, said in the release. “The IlluminOss System was developed with an aim to provide improved patient experiences and outcomes when treating pathologic fractures. There is a critical need to make less invasive orthopedic fracture repair options available to an aging and underserved market segment.”