FDA Clears IlluminOss’s New Light Console for Implants

IlluminOss Medical has received U.S. Food and Drug Administration (FDA) 510(k) clearance for a new Light-Emitting Diode (LED) Console to speed curing of its patented, light-cured implants.
 
IlluminOss claims to be the first and only company to develop balloon-like implants for supporting and repairing fragile and geriatric bone. The implants are inserted through a minimally invasive procedure into the patient’s bone canal and are then infused with light-curing liquid. Next, a fiber optic cable transfers a specific wavelength of blue light from the Light Console to cure the implant. The new console reduces the implant hardening time, in some cases by up to 50%, which may decrease operative time and save hospital costs. By providing structural strength to fractured or weakened bone, IlluminOss implants give patients the opportunity for early mobility and return to daily living activities while also delivering a strong attachment for surgical plates and screws if necessary.
 
“The light-curing of the implant is kind of a magical time in the OR because of the glowing, blue light fiber,” said Charles Moon, M.D., of Los Angeles. “It’s a visual cue that we are using state-of-the-art technology to heal a patient who would have been much more difficult to treat a few years ago when there was no great solution for augmenting their fragile bone. With IlluminOss, many of our patients are more reliably treated and regain their mobility.”
 
Although the original IlluminOss Light Console performs well, the company has embraced modern technologies with this new design to improve efficiency while reducing the console size by approximately 40%. The most important advancement is incorporating LEDs as the light source instead of a metal halide bulb. LEDs last much longer than bulbs and speed the curing time of the liquid inside the balloons.
 
“I am impressed with how the IlluminOss technology helps me deliver a life changing result to my patients,” stated Steve Morgan, M.D., of Denver. “The company has always focused on R&D to optimize patient results, and this new Light Console will benefit both patients and our operating room staff.”
 
Headquartered in East Providence, R.I., IlluminOss is a privately held, commercial-stage medical device company offering minimally invasive technology for fracture repair and stabilization. The company uses a light-curable monomer contained within an expandable balloon to create a patient-conforming intramedullary implant for bone stabilization. The minimally invasive technology is applicable for repairing and treating osteoporotic and compromised bone. The original IlluminOss system is CE-marked and cleared by the FDA for various anatomical sites, with further indications pending.