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IlluminOss Medical Completes Enrollment for U.S. Clinical Trial of Photodynamic Bone Stabilization -

IlluminOss Medical completed enrollment in its 1st U.S. clinical trial of its Photodynamic Bone Stabilization System for the treatment of fractures using patient-specific intramedullary implants. Outcomes data from the 13-site, 80-patient trial will support submission of a DeNovo marketing application to FDA in pursuit of a potential 2017 U.S. market clearance for the device.

Ex-U.S., the system has been approved for clinical use since 2010, and to date, it has been used to treat >1,500 patients worldwide.

The IlluminOss Photodynamic Bone Stabilization System is CE Mark approved for fracture alignment reduction in light to low load-bearing bones. The system utilizes a light-curable polymer, contained within an expandable PET balloon catheter, to achieve bone stabilization. The procedure is performed through a small percutaneous surgical approach. Surgeons can use the product alone or with traditional hardware and screws to treat a variety of fractures. The cured implant conforms to the geometry of a patient’s intramedullary canal, whereas traditional rigid IM rods have only small discrete contact points. (Source: NOTABLE U.S. COMPANIES IN FRACTURE REPAIR, ORTHOWORLD, August 2014)

Sources: IlluminOss Medical, ORTHOWORLD Inc.

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