Medtronic has received CE Mark (Conformité Européenne) for its ReDuX Plier, a new instrument specially intended for use during osteotomies.
With the approval, the company has also announced the launch of the surgical instrument designed for the spinal orthopaedic industry.
According to the company, European physicians can now perform a more controlled osteotomy closure for people with a severe form of spinal curvature.
Medtronic Spinal & Biologics Western Europe and Canada vice-president Steve Swinson said, "ReDuX Plier is just one example, a device which can tackle complex conditions."
The ReDuX Plier has been designed for use, most specifically in pedicle substraction osteotomy (PSO).
PSO is a complex and delicate surgical procedure for patients with sagittal imbalance, a condition where the back has lost its characteristic S-shape that allows the skeleton to resist gravity and make people stand upright.
During a PSO surgery, a triangular wedge of bone is removed from the middle of a vertebrae, allowing it to be angled backwards to re-align the spine by increasing the backward curve (lordosis) in the lower (lumbar) part of the spine. This enables patients to have upright posture, besides relieves them of pain.
Surgical procedures that remove bone from the spine, such as PSO, can be complicated.
It could also be compounded with problems such as collapse of vertebrae when compression is applied to close the two sides left after the removal of bone.
However, as the ReDuX Plier is connected directly to the implants, it aims to protect the front of the vertebrae from collapse by driving the kinematic of the closure and dissipating stress onto the bone screws.
Besides, ReDuX Plier provides a progressive correction, ensuring a more controlled procedure at every stage of the operation.