IlluminOss receives FDA clearance for photodynamic bone stabilization system
IlluminOss Medical has received FDA 510(k) clearance for the clinical use of its photodynamic bone stabilization system, according to a company press release.
The system, which utilizes a patient-specific intramedullary implant, is designed for the treatment of pelvic, clavicle and small bone fractures, such a metacarpals, metatarsals and phalanges. It also deploys a liquid polymer inside an expandable balloon to create a rigid implant within the bone canal, according to the release.
“The new indication expansion significantly broadens the opportunities to address the geriatric fragility fracture market where patients often have poor bone quality,” Robert Rabiner, IlluminOss chief technology officer, said in the 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 postoperative opioids,” he added.
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