IlluminOss Medical has completed patient enrollment in its first US clinical trial in a bid to seek approval from the US Food and Drug Administration (FDA) for its IlluminOss System to treat fractures using patient-specific intramedullary implants.
The trial will be conducted across 13 surgical sites and will include 80 patients with fractures in the humerus due to metastatic carcinoma.
University of Pittsburgh Medical Center musculoskeletal oncology chief Dr Richard McGough said: “We have seen that the IlluminOss implant can be a game changer for patients with humeral metastatic disease.
“This technology allows us to stabilise 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.”
The device involves a minimally invasive procedure which uses a thin walled PET balloon that contains liquid monomer being inserted into the intramedullary canal of the bone assuming the shape of the patient’s specific bone.
It creates a tough implant after the surgeon activates the visible light delivered within the PET balloon.
It imparts longitudinal strength and rotational stability across the length of the implant.
Memorial Sloan Kettering Cancer Center Stephen McDermott Chair in Surgery orthopaedic service chief Dr John Healey said: “The IlluminOss System is a transformative technology, providing versatility in the way advanced fracture repair can be approached and enabling orthopedic surgeons to extend the functional benefits of surgical stabilisation to more patients while also allowing them to preserve the rotator cuff.”
Till date, more than 1,500 patients across the world have been treated with the IlluminOss System resulting in rapid post-procedure patient mobility with smaller incisions and shorter procedure times.