IlluminOss Medical received conditional approval from the U.S. Food and Drug Administration for a clinical trial to study the safety and efficacy of its Photodynamic Bone Stabilization System in treating impending and pathologic fractures.
The system is the only system of its kind and offers advantages for the treatment of complex fractures, particularly those caused by metastatic carcinoma. It is commercially available in international markets and has been in clinical use since 2010.
The 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.
Martin Malawer, MD, director, orthopedic surgical oncology and professor of orthopedic surgery at George Washington University Hospital and professor of orthopedic surgery at Georgetown University, will lead the trial. "From what I have seen to date, IlluminOss' Photodynamic Bone Stabilization System could prove to be a true disruptive technology in the treatment of pathological and non-pathological fractures by orthopedic surgeons," said Dr. Malawer. "This technology will potentially reduce surgery time and morbidity rates, as well as lessen complications and improve patient outcomes."
IlluminOss expects to begin enrolling clinical sites and initiate the trial shortly.
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