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.