IlluminOss Medical is entering the U.S. trauma market with the launch of its photodynamic bone fixative, which helps stabilize and heal arm fractures linked to fragility in an ever-aging population.
The orthopedic polymer system includes an expandable balloon implant, which is inserted into the bone cavity through a minimally invasive procedure.
The implant is then filled with a liquid monomer solution, which expands the balloon and conforms to the shape of the bone’s intramedullary canal. Afterward, the solution is cured using visible blue light, stabilizing the fracture as it hardens.
The FDA cleared the system in August 2018 to treat traumatic, fragility, pathological and impending fractures of the arm’s humerus, radius and ulna in skeletally mature patients.
“With a rapidly increasingly geriatric population, we are seeing a significant rise in these fracture patterns, which are often associated with osteoporosis and/or other pathologic indications affecting bone quality,” IlluminOss CEO Jeff Bailey said in a statement. “Osteoporotic bones can be difficult to treat with conventional hardware such as plates, nails and screws, as reduction and subsequent hardware fixation may be difficult.”
The system had first received a de novo clearance in January 2018 for arm fractures associated with bone metastases. It can also be used with other cleared fracture-fixation hardware—including nails, plates and screws placed in the implant itself—to provide supplemental support in the humerus, radius and ulna bones, the company said.
According to IlluminOss, surgeons have reported reduced hospital stays, shorter procedure times and less postoperative pain and medication use.