Novel Treatment for Fragile, Osteoporotic Bone Fractures Cleared

lluminOss Medical, headquartered in East Providence, Rhode Island, has announced that its Photodynamic Bone Stabilization System has received additional clinical clearance and is now indicated by the U.S. Food and Drug Administration (FDA) for use in skeletally mature patients in the treatment of traumatic, fragility, pathological, and impending pathological fractures of the humerus, radius and ulna.

“IlluminOss’ minimally invasive approach is ideal for treating patients suffering from fragility fractures. 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,” said Jeff Bailey, CEO, IlluminOss Medical. “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.”

Using the IlluminOss System, the physician can create a patient-conforming implant capable of delivering strength and stability over the entire length of the implant and, thereby, support weakened bone. The system supports minimally invasive interventions, smaller incisions and may help reduce soft tissue injuries.

According to the company, surgeons using the IlluminOss System have reported shorter procedural times which, of course, translates into patients leaving the hospital sooner with less post-operative pain and less analgesic pain medication.

“As people age they lose bone density and are more prone to osteoporosis which increases their risk of incurring fragility fractures,” said Marc Guijt, M.D., University of Amsterdam. “Using the IlluminOss System, even patients with highly compromised bone quality may be treated in order to speed their return to daily activities and reduce complications. This has the potential to revolutionize the way fracture repair for the elderly may be approached.”

Jeff Bailey told OTW, “We want orthopedic surgeons to know that there is now a minimally invasive option available for the treatment of traumatic, fragility, pathological, and impending pathological fractures that may improve outcomes for their patients with frail bones—such as the elderly, osteoporotic or those with metastatic bone disease.”

“With our technology, surgeons don’t have to worry about affixing conventional hardware such as plates, nails and screws to brittle or low-density bones—which can be very challenging and not optimal for the patient. The IlluminOss System incorporates the use of a thin-walled PET [positron emission tomography] balloon that is infused with a liquid monomer which is delivered in a minimally invasive fashion into the intramedullary canal of the bone through a small incision. Once the balloon is infused with monomer, it conforms to the shape of the patient’s specific bone. The surgeon then activates a light source which delivers visible light to the PET balloon, polymerizing the monomer nearly instantly. The cured, hardened implant provides longitudinal strength and rotational stability over the length of the implant, stabilizing the fracture.”

Asked about the clinical clearance process, he commented to OTW, “The clinical clearance process required our regulatory team to work diligently, and they were ultimately able to help deliver a timely U.S. FDA clearance that we believe will help address previously unmet patient needs going forward.”