IlluminOss Medical has received expanded US Food and Drug Administration (FDA 510k) clearance for its photodynamic bone stabilisation system for treatment of fractures of the fibula.
The system has been developed as a minimally invasive approach for fracture repair and stabilisation, using a patient-specific intramedullary implant.
Using a light-curable liquid monomer contained within an expandable balloon, the system delivers a ‘patient-conforming’ rigid implant inside the bone canal.
The IlluminOss System was previously cleared by the FDA for the treatment of traumatic, fragility, pathological and impending pathological fractures of the humerus, radius, ulna, clavicle, pelvis, metacarpals, metatarsals and phalanges.
The system is also approved for use in combination with FDA-cleared fracture fixation systems to offer supplemental fixation in all cleared anatomic sites.
IlluminOss chief technology officer Robert Rabiner said: “The IlluminOss technology offers a minimally invasive approach that spares soft tissues, which may lower the risk of wound complications, and can potentially drive better functional outcomes, including a faster return to weight-bearing and daily activities.
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“Fractures of the fibula, one of the long bones of the lower leg, are among the most common and can be particularly challenging to manage in elderly patients. Additionally, current treatment approaches such as plating have several disadvantages, including larger incisions and the potential for meaningful patient discomfort.”
According to the company, the IlluminOss technology has been in clinical use in Europe for a decade with approximately 4,000 procedures carried out.
In 2016, the company completed patient enrollment in its first US clinical trial for the system to treat fractures.
Commenting on the development, IlluminOss chairman Mike Mogul said: “Quickly returning elderly fracture patients to the activities of daily living remains a significant challenge or opportunity in orthopaedics.
“The fibula clearance, in addition to the recently approved pelvic and clavicle indications, is yet another step toward IlluminOss’ goal of providing minimally invasive fracture care in the majority of fractures faced by those elderly patients.”