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The IlluminOss Photodynamic Bone Stabilization System (PBSS) is indicated for skeletally mature patients in the treatment of impending and actual pathological fractures of the humerus, radius, and ulna, from metastatic bone disease.

The IlluminOss Photodynamic Bone Stabilization System (PBSS) is intended to be used in the fixation and stabilization of actual and impending pathological fractures of the humerus, radius, and ulna through a minimally invasive procedure. The system uses a catheter to deploy an inflatable, noncompliant, thin wall PET balloon into the medullary canal of the bone across the fracture site. The balloon is infused using a standard 20cc syringe with a photodynamic (light cured) monomer that causes the balloon to slowly expand and fill the intramedullary canal of the fractured bone. Activation of the light system allows for visible spectrum light to be delivered through a radially emitting light pipe that is temporarily positioned within a central lumen of the catheter that runs the length of the balloon. The liquid monomer within the balloon is exposed to light along the entire length of the balloon during the curing process. Curing (and hardening) occurs only when the photo initiator within the monomer is exposed to a specific frequency of light causing rapid polymerization of the monomer resulting in a solid intramedullary (IM) rod. The time to cure the IM rod depends on the size of the balloon used to stabilize the fracture. A Timer Kev, included within each balloon catheter kit, determines the time the light source is activated during the curing process to ensure the appropriate cure time is used for each balloon size.