IlluminOss Medical recently announced that it received FDA 510(k) clearance for expanded use of its Photodynamic Bone Stabilization System.
The system is designed to treat fractures in the pelvis, clavicle and small bones of the hands and feet. It is a minimally invasive approach for fracture repair and stabilization in a patient-specific intramedullary implant.
“The new indication expansion significantly broadens the opportunities to address the geriatric fragility fracture market where patients often have poor bone quality,” chief technology officer Robert Rabiner said in a news release. “An example would be fractures of the pelvis; IlluminOss is deployed through a small, minimally invasive, tissue-sparing incision. Our system conforms to the curvature of the pelvis, and in a simple procedure provides strength and stability to the fracture. Surgeons report their patients have a rapid return to function, which is crucial for this patient population, as well as significant reduction in the use of post-operative opioids.”
IlluminOss’s System features a light-curable liquid polymer that is contained within an expandable balloon that creates a patient-conforming, rigid implant in the bone canal.
The technology was previously FDA cleared for treatment of traumatic, fragility, pathological and impending pathological fractures of the humorous, radius and ulna.
“The feedback we received from the surgeons using IlluminOss in Europe described case after case of bed-ridden, elderly pelvic fracture patients up and walking the day after this very minimally invasive surgery,” said Mike Mogul, Chairman of IlluminOss. “With this indication expansion, we are excited to bring the benefits of our technology to the US patient population as well.”