IlluminOss Medical commenced U.S. launch of the IlluminOss® Bone Stabilization System to treat traumatic and fragility fractures of the humerus, radius and ulna.
IlluminOss received its initial de novo FDA clearance in 4Q17 for fractures associated with metastatic bone; FDA 510(k) clearance for traumatic and fragility fractures was received in 3Q18. Ex-U.S., the system has been commercially available since 2010.
The procedure uses a light-curable liquid monomer, contained within an expandable PET balloon catheter, to achieve stabilization in poor quality/compromised bone. This is delivered through a small percutaneous incision. Once the implant is cured and polymerized, it conforms to the geometry of a patient’s intramedullary canal.
Source: IlluminOss Medical, Inc.