IlluminOss Medical Inc., a medical device company developing the innovative IlluminOss™ Photodynamic Bone Stabilization System for orthopedic surgery, today announced that it had been granted a CE Mark. The approval permits the Company to market this product in the European Union (EU).
IlluminOss Medical is beginning the process of selecting distribution partners in the EU for the IlluminOss Photodynamic Bone Stabilization System.
With traditional methods of treating fractures, often a large incision has to be made; and plates and screws inserted to stabilize the fracture. There may be extensive soft tissue damage; the patient has limited or no mobility initially which may lead to temporary or permanent stiffness; and the patient may experience severe pain.
The IlluminOss Photodynamic Bone Stabilization System requires just a small 4.5mm pathway into the bone to stabilize it. A small diameter balloon catheter and light fiber are inserted into the intramedullary canal of the bone. A photo sensitive, liquid monomer is then infused into the balloon. The monomer expands the balloon to fit the contours of the interior of the bone, aiding in the reduction of the fracture. Then the light source is activated, converting the liquid monomer into a hardened polymer within 90 seconds. The minimal skin incision is then closed.
Unlike other methods of fracture treatment, the IlluminOss Photodynamic Bone Stabilization System is designed to enable the patient to have immediate joint mobility post procedure without the need for immobilization. Due to the minimally invasive approach, soft tissue injury is virtually eliminated. Having immediate mobility minimizes the potential for tendon adhesions and a tenolysis procedure to remove them.
According to Bob Rabiner, Founder and CEO of IlluminOss Medical, “This approval represents a major milestone for IlluminOss and patients in the EU. We believe that our minimally invasive technology will fundamentally improve the treatment of hundreds of thousands of bone fractures by driving much earlier restoration of functionality, improving the durability of orthopedic repairs, decreasing pain and reducing scarring.”
Source: IlluminOss Medical Inc.