By: 11 August 2016
IlluminOss Medical completes enrollment for US clinical trial using photodynamic bone stabilisation system

Minimally Invasive System May Offer Significant Advantages to Surgeons Treating Impending and Pathologic Fractures using Patient-Specific Implants

IlluminOss Medical, a privately-held, commercial stage medical device company focused on minimally invasive orthopaedic fracture repair, announced in July it has completed enrolment in its first US clinical trial towards FDA approval of its IlluminOss System, the world’s first and only system of its kind which supports the treatment of fractures using patient-specific intramedullary implants.

Thirteen surgical sites around the country participated in the trial, which included 80 patients – all with impending or pathologic fractures in the humerus due to metastatic carcinoma.

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.

The IlluminOss implant was developed as an alternative to currently used nails and plates, with the potential to provide better patient experiences and outcomes. This novel approach to fracture repair has proven successful in international markets, where the IlluminOss System has been approved for clinical use since 2010. To date, it has been used in the treatment of over 1,500 patients worldwide and has been observed to result in smaller incisions, shorter procedure times, and more rapid post-procedure patient mobility with reduced hospital stays and lower complication rates for patients.

“The IlluminOss System is a transformative technology, providing versatility in the way advanced fracture repair can be approached and enabling orthopaedic surgeons to extend the functional benefits of surgical stabilisation to more patients while also allowing them to preserve the rotator cuff,” said John Healey, chief, Orthopaedic Service; Stephen McDermott Chair in Surgery at Memorial Sloan Kettering Cancer Center.

“We’ve 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,” said Richard McGough, 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.”