The U.S. FDA has granted IlluminOss Medical conditional approval to conduct a clinical trial for the treatments of impending and pathologic fractures in the humerus due to metastatic carcinoma.
IlluminOss Medical is a privately-held medical device company focused on minimally invasive orthopedic fracture repair. Its clever Photodynamic Bone Stabilization System (PBSS) is the world’s first and only system of its kind and claims to offer significant advantages for the treatment of complex fractures. It is commercially available in international markets and has been in clinical use since 2010, having been CE marked in 2009.
The 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 as an 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.
IlluminOss’ novel approach has proven successful in its widespread use in Europe, where PBSS has been used in the treatment of over 700 patients. Benefits observed from the use of the product in patients include smaller incisions, shorter procedure times, and more rapid postprocedure patient mobility with reduced hospital stays and lower complication.
IlluminOss expects to begin enrolling clinical sites and initiate its first trial shortly led by Dr. Martin Malawer, director, Orthopedic Surgical Oncology and Professor of Orthopedic Surgery at George Washington University Hospital and Professor (Clinical Scholar) of Orthopedic Surgery at Georgetown University. Dr. Malawer is widely respected for pioneering many surgical techniques used today in cancer centers throughout the world. In the trial, he will be applying IlluminOss’ technology to the treatment of metastatic lesions.
“From what I have seen to date, IlluminOss’ Photodynamic Bone Stabilization System could prove to be a true disruptive technology in the treatment of pathological and non-pathological fractures by orthopedic surgeons,” said Dr. Malawer. “This technology will potentially reduce surgery time and morbidity rates, as well as lessen complications and improve patient outcomes.”
“We have been exceedingly pleased with the results that surgeons internationally have achieved using our Photodynamic Bone Stabilization System and we are confident that we will see similar enefits for patient outcomes in the U.S. clinical trials,” said Robert Rabiner, president & founder of IlluminOss Medical. “Obtaining this FDA approval has been the vital first step towards ultimately applying our technology to the treatment of fractures in the U.S. and we look forward to serving this critical market.”
Source: IlluminOss Medical, Inc.