IlluminOss photodynamic bone stabilization system receives EU
approval
7 April 2009
IlluminOss Medical Inc., has been granted a CE Mark. for its
innovative IlluminOss photodynamic bone stabilization system for
orthopaedic surgery. 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 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 fibre 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."
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