Providence Business News
PBN Staff
IlluminOss Medical has received conditional approval from the federal Food and Drug Administration to conduct a clinical trial for treatments of impending and pathologic fractures in the humerus due to metastatic carcinoma. IlluminOss Medical, a privately held, commercial medical device company that focuses on minimally invasive orthopedic fracture repair, said that it expects to initiate the trial shortly. The company said that its Photodynamic Bone Stabilization System offers advantages for the treatment of complex fractures. It is commercially available in international markets and has been in clinical use since 2010.
“IlluminOss’ novel approach has proven successful in its widespread use in Europe, where PBSS has been used in the treatment of more than 700 patients. Benefits observed from the use of the product in patients include smaller incisions, shorter procedure times and more rapid post-procedure patient mobility with reduced hospital stays and lower complication rates,” the company said in a news release.
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.
Dr. Martin Malawer, director, orthopedic surgical oncology and professor of orthopedic surgery at George Washington University Hospital, will lead the first U.S. trial of PBSS. Malawer said the technology could potentially reduce surgery time and complications. In the trial, he will be applying IlluminOss’ technology to the treatment of metastatic lesions. Robert Rabiner, president and founder of IlluminOss Medical, said that the company has been pleased with the results surgeons internationally have experienced using the Photodynamic Bone Stabilization System.
“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,” Rabiner said.
Original Article | Nov 20, 2014