CE Mark Granted to Medtronic Osteotomy Device

Medtronic Inc., a maker of medical devices based in Minneapolis, Minn., has been granted CE Mark approval for its Redux plier, a new instrument designed for use during osteotomies. According to the company, this tool allows surgeons to perform a more controlled osteotomy closure for people with a severe form of spinal curvature. An osteotomy is a surgical operation whereby a bone is cut to shorten, lengthen, or change its alignment.

The Redux plier was developed by the Tolochenaz, Switzerland-based Medtronic European Product Development Office, building on an original invention by Jean-Charles Le Huec, M.D., chief of the company’s spine unit and chair of the department of orthopedics and traumatology at the Bordeaux University Hospital, France.

Adult spinal deformity poses many challenges to spine surgeons. In particular, a substantial imbalance in the sagittal plane sometimes cannot be corrected solely with a standard arthrodesis procedure. In these cases, spinal osteotomies must be performed to restore balance in both the sagittal and the coronal planes.

The Redux plier reportedly is well-suited for pedicle subtraction osteotomy (PSO). PSO is a complex and delicate surgical procedure for patients with sagittal imbalance, a condition where the back has lost the characteristic S-shape that allows the skeleton to resist gravity and keep people standing upright. These patients can live in considerable pain, unable to stand or walk properly.

During a PSO 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) spine. This creates a more upright posture and relieves pain.

Surgical procedures that remove bone from the spine, such as PSO, can be extensive and complicated. Problems can include the collapse of vertebrae when compression is applied to close the two sides left after the removal of bone. 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. The device also provides a progressive correction, ensuring a more controlled procedure at every stage of the operation, claims Medtronic.

“The PSO procedure is an extremely powerful option for people with severe spinal curvatures, but the potential for complications has historically been very high,” said Le Huec, speaking at the Société Française de Chirurgie Rachidienne congress in Nice, France, in June. “The instruments currently available were often too crude for the complex procedure, so working with Medtronic we have been able to produce specially-designed instruments which give surgeons greater control than ever before.”

“Medtronic is delighted to have worked with Professor Le Huec to make the Redux plier available in Europe,” said Steve Swinson, vice-president of Medtronic Spinal & Biologics Western Europe and Canada. “Medtronic has a history of working with surgeons to turn ideas into practical improvements for patients. Redux plier is just one example, a device which can tackle complex conditions. This is part of Medtronic’s commitment to alleviating pain and restoring health for people all over the world.”

Redux plier is available for use across Europe. The product is not yet commercially available in the United States.