IlluminOss Medical is diving into a new clinical trial to test its photodynamic bone stabilization system as a treatment for osteoporotic and fragility fractures.
The IlluminOss system uses a light-curable polymer, delivered in an expandable balloon catheter, to stabilize bone. The 1st patient in the trial – an elderly female with a proximal humerus fracture stemming from a fall – was treated at Albert Schweitzer Hospital in the Netherlands. IlluminOss, which is based in Providence, R.I., and Holland, said the treatment is part of its EU Light Fix Proximal Humerus Fracture Repair Trial.
The patient was able to go home a day after the surgery with a small sling and reported being nearly "pain-free," lead investigator Dr. Paul Vegt said in prepared remarks.
"The growing elderly population has many people concerned about quality of care and healthcare costs," Vegt said. "The IlluminOss system – which I have been using on a regular basis in my clinical practice – may prove to be the answer to making healthcare less expensive for fracture sufferers by potentially enabling them to leave the hospital sooner, regain their independence more quickly without the hindrance of a hard cast, and require less post-procedure care once they are discharged. I am excited by this new product, as IlluminOss’ technology expands the surgical indications that I am now able to treat in this minimally invasive way."
IlluminOss is moving ahead with a new trial a few months after gaining FDA conditional clearance to start another trial of its device in upper arm fractures relating to metastatic cancer. The device has had CE Mark approval in the European Union since 2009.
