IlluminOss Receives 510K Clearance for a New Light Console for its Implants that Provide Strength for Fragile and Geriatric Bone
New Console Reduces Curing Time by up to 50%
EAST PROVIDENCE, R.I., Jan. 31, 2024 /PRNewswire/ — By combining years of clinical experience with cutting-edge research and development, IlluminOss Medical announces it has received FDA 510(k) clearance for a new Light-Emitting Diode (LED) Console to speed curing of its patented, light-cured implants.
IlluminOss is 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 provide patients with an 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,” says Charles Moon, MD in Los Angeles, California, “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 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,” says Steve Morgan, MD from Denver, Colorado, “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.”
About IlluminOss Medical, Inc.
Headquartered in East Providence, RI, IlluminOss is a privately held, commercial-stage medical device company offering a unique, minimally invasive technology for fracture repair and stabilization. The company utilizes a light-curable monomer contained within an expandable balloon to create a patient-conforming intramedullary implant for bone stabilization. The revolutionary, minimally invasive technology is applicable for repair and treatment of osteoporotic and compromised bone. The original IlluminOss system is CE-marked and FDA-cleared for a variety of anatomical sites, with further indications pending. This new LED Light Console and its implants received 510k clearance for the US. For additional information, including a complete list of indications, contraindications, warnings, precautions and risks, visit www.illuminoss.com.
For any press questions, please contact Lisa Holt, at lholt@illuminoss.com.
SOURCE IlluminOss Medical
