FDA grants IlluminOss marketing clearance for bone stabilization system

The FDA granted IlluminOss Medical de novo clearance for its IlluminOss Bone Stabilization System. 

The stabilization system treats impending and actual pathological fractures of the humerus, radius and ulna that are caused from metastatic bone disease. It does this by using a thin-walled PET balloon that is infused with a liquid monomer. Physicians deliver the system in a minimally invasive fashion into the intramedullary canal of the bone.

Once infused with monomer, the device conforms to the shape of a patient's bone.

The system has been available internationally since 2010. This will be the first time it is commercially available in the U.S.

IlluminOss plans to start commercialization efforts in the second quarter of fiscal year 2018.

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