IlluminOss Medical receives FDA clearance for bone stabilization system


IlluminOss-logoIlluminOss Medical recently announced that it received FDA clearance for its Photodynamic Bone Stabilization System.

The clearance allows the system to be used in skeletally mature patients for treating traumatic, facility, pathological and pathological fractures of the humerus, radius and ulna.

“IlluminOss’s 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,” Jeff Bailey, CEO of IlluminOss Medical, said. “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.”

A patient-conforming implant can be created using the IlluminOss System to give strength and stability to the whole implant that is supporting a weakened bone. Since it is used in a minimally invasive way, smaller incisions are able to be used and soft tissue injuries are reduced. Shorter procedure times, patients retuning to daily living activities faster, less post-operative pain, less use of analgesic pain medicals and reduced hospital stays were all reported by surgeons who have used the IlluminOss System.

“As people age, they lose bone density and are more prone to osteoporosis, increasing their risk of incurring fragility fractures,” said Dr. Marc Guijt from the 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.”

The IlluminOss System originally received FDA clearance in January this year for fractures from metastatic bone disease in the U.S.

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