IlluminOss Medical, Inc. has announced it has completed enrollment in its first U.S. clinical trial towards FDA approval of its IlluminOss System. According to the company, this is the world’s “first and only system of its kind that supports the treatment of fractures using patient-specific intramedullary implants.” The 80-patient U.S. trial took place at 13 sites; all of the patients had impending or pathologic fractures in the humerus due to metastatic carcinoma.
As indicated in the July 18, 2016 news release, “IlluminOss’ minimally invasive procedure incorporates the use of a thin walled PET balloon that is infused with a liquid monomer and inserted into the intramedullary canal of the bone conforming to the shape of the patient’s specific bone. The device forms a hardened implant once the surgeon activates the visible light delivered within the PET balloon. Once cured, the implant provides longitudinal strength and rotational stability over the length of the implant.”
“We’ve seen that the IlluminOss implant can be a game changer for patients with humeral metastatic disease. This technology allows us to stabilize the bone with less pain, less surgical time, and less difficulty for the patients. We can therefore treat this problem on an outpatient basis in some patients, and can condense treatments fairly dramatically, ” said Richard McGough, M.D., chief of Musculoskeletal Oncology at the University of Pittsburgh Medical Center. “I’m very excited by where this can go in the future, pending FDA approval, as I think this technology could allow us to treat conditions we formerly could not, and can offer ways to treat cancer in the skeleton that were previously impossible.”
“We are pleased to have completed enrollment in our U.S. trial and exceedingly satisfied with the feedback we have received so far from participating surgical sites, ” said Manny Avila, president and CEO of IlluminOss. “Consistent with what we have observed in international use cases, the IlluminOss System has demonstrated benefits to both orthopedic surgeons and their patients. The IlluminOss implant has the potential to redefine how complex fracture repair may be approached pending FDA clearance.”
Avila told OTW, “The orthopedic market is ripe for disruption and we already have very compelling results from international use of our technology and we have had a very positive response in the U.S. during our trial enrollment. Although surgeons were generally excited for the opportunity to try our unique and less invasive approach to complex fracture repair, there is still a good amount of education that has to go in to preparing the market. Peer-to-peer education between orthopedic surgeons on how our approach may produce better results for them was essential to driving trial participation and, pending FDA approval, will be important for widespread adoption of the IlluminOss System.”
