IlluminOss Medical Completes Enrollment for U.S. Clinical Trial Using Groundbreaking Photodynamic Bone Stabilization System
EAST PROVIDENCE, RI (July 18, 2016) – IlluminOss Medical, a privately-held, commercial stage medical device company focused on minimally invasive orthopedic fracture repair, today announced it has completed enrollment in its first U.S. clinical trial towards FDA approval of its IlluminOss System, the world’s first and only system of its kind which supports the treatment of fractures using patient-specific intramedullary implants. Thirteen surgical sites around the country participated in the trial, which included 80 patients — all with impending or pathologic fractures in the humerus due to metastatic carcinoma. IlluminOss’ minimally invasive procedure incorporates the use of a thin walled PET balloon that is infused with a liquid monomer and inserted into the intramedullary canal of the bone conforming to the shape of the patient’s specific bone. The device forms a hardened implant once the surgeon activates the visible light delivered within the PET balloon. Once cured, the implant provides longitudinal strength and rotational stability over the length of the implant.
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