Newly published data shows that percutaneous intramedullary fixation using a light-curable polymer, can provide for stabilization of bone fractures while avoiding the need for large tissue-dissections.
It’s six years since we first covered the technology that is the IlluminOss® System, since which time it’s gained CE mark approval for marketing in Europe and more recently undertaken clinical trial work in the U.S. under the auspices of not-for-profit preclinical research institute, CBSET. Data from these studies has now been published in the Journal of Biomedical Materials Research Part B: Applied Biomaterials
The IlluminOss System combines the use of proven medical polymers and traditional balloon catheter technology to provide a completely new technology for patient-specific, percutaneous orthopedic implants. The implant begins as a liquid monomer that is completely contained within a Dacron or PET balloon. Once inside a patient’s bone, it conforms to the geometry of that patient’s intramedullary canal, in contrast to traditional rigid intramedullary rods, which have only small discrete contact points.
The system is commercially available for approved clinical applications in Europe and other international markets through both a direct sales force and distribution networks, giving international surgeons the option to use it alone or in conjunction with traditional hardware and screws for multiple types of fractures.
Up next we expect to see results from human trials in the U.S. as flagged by this post last November (2014). It details a clinical trial for the treatments of impending and pathologic fractures in the humerus due to metastatic carcinoma.
“Our study validates the intramedullary application of a light-curable photodynamic bone stabilization system from study sponsor IlluminOss Medical as a biocompatible and feasible method for fracture fixation repair in load-bearing bones, such as the long bones of the leg,” said principal investigator Brett G. Zani, Ph.D., Director of Applied Sciences, CBSET. “The data demonstrated that PBSS did not disrupt bone formation when injected into intact bones, but did lead to increasing levels of cortical bone from 8 to 26 weeks when used in the fracture gap.”
“IlluminOss represents a significant innovation in orthopedic trauma, providing patients with fracture fixation options that are metal-free and delivered in a minimally-invasive manner,” said Peter Markham, President, CEO and a co-founder of CBSET. “We are proud to have helped IlluminOss validate its novel technology. Since 2006, we have set the medtech gold standard for cutting-edge preclinical science, helping more than 400 companies transform their early-stage concepts into innovative therapies.”