IlluminOss Medical said the FDA granted "conditional" clearance for a clinical trial of its photodynamic bone stabilization system, ahead of its bid for de novo clearance from the watchdog agency.
The IlluminOss system uses a light-curable monomer administered into the bone via a balloon catheter. The monomer hardens into a polymer implant when the surgeon activates a light contained in the balloon, according to a press release. The trial will examine the use of the device for treating upper arm fractures due to metastatic cancer, IlluminOss said.
"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 benefits for patient outcomes in the U.S. clinical trials," president & founder Robert Rabiner said in prepared remarks. "Obtaining this FDA approval has been the vital 1st step towards ultimately applying our technology to the treatment of fractures in the U.S. and we look forward to serving this critical market."
The IlluminOss device won CE Mark approval in the European Union in 2009.
“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. Martin Malawer of the George Washington University Hospital, who is slated to lead the first U.S. trial. “This technology will potentially reduce surgery time and morbidity rates, as well as lessen complications and improve patient outcomes.”