One-Year Study Results: Percutaneous Application of the IlluminOss System

By Julie A. Vetalice

Study results indicate that percutaneous intramedullary fixation, such as that provided by the IlluminOss system, can provide stabilization of long bone fractures without open surgery.

Results of this study were published in the Journal of Orthopaedic Research.

The rabbit study evaluated percutaneous application of the IlluminOss light-curable photodynamic bone stabilization device, developed by IlluminOss Medical for fracture stabilization and repair. Biocompatibility evaluations comparing IlluminOss to K-wire implants showed no significant long-term local tissue reactions from either implant, as well as good systemic biocompatibility of the IlluminOss system at one year.

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 have the freedom to use the product alone or in conjunction with traditional hardware and screws for multiple types of fractures. The cured implant conforms to the geometry of a patient’s intramedullary canal, whereas traditional rigid intramedullary rods have only small discrete contact points. (Excerpted from Notable U.S. Companies in Fracture Repair, ORTHOWORLD, August 2014)

In 3Q16, IlluminOss Medical completed enrollment in its first U.S. clinical trial of its Photodynamic Bone Stabilization System in 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.

Sources: IlluminOss Medical, Inc.; ORTHOWORLD Inc.

Product Labels: Upper Extremity, Lower Extremity

Tags: Trial/Study