CE Mark For Medtronic’s CD Horizon BalanC™Spinal System

In short

Medtronic, Inc. has announced the gaining of CE Mark and the international launch of the CD HORIZON BalanC™ Spinal System. The launch expands the options for physicians outside the United States in treating multi-level spinal surgeries requiring fusion at one or more levels and neutral stabilization (non fusion) at an adjacent level for common spine conditions such as spinal stenosis and early stage degenerative disc disease.

Background

The CD HORIZON BalanC™ Rod is a neutral stabilization rod with a unique combination of polyetheretherketone (PEEK) and silicone materials and geometry. The system is intended to help provide stabilization and/or immobilization of spinal segments of the lumbar and/or sacral spine for the pathologies of spinal stenosis, spondylolisthesis, and degenerative disc disease.

Achieving sagittal balance of the spine is a critical goal for the spinal surgeon. Maintaining or restoring the lordosis, the natural curve of the lumbar spine, avoids mechanisms of compensation that will increase lumbar pain and stress on the lumbar-pelvic spine.

Consequently, to create a construct that matches different patients’ balance profiles, the CD HORIZON BalanC™ Rod is offered in four different curvatures.

The non-fusion portion of the rod has a c-shaped section to help control the amount of motion at the adjacent segment while maintaining appropriate durability performance.

Additionally, the CD HORIZON BalanC™ rod is radiolucent, meaning it does not show up on x-rays, which allows the surgeon to view the quality of the spinal fusion using x-ray or fluoroscopy during a follow-up visit.

According to Medtronic, computational analysis and mechanical testing (which it admits may not be indicative of clinical outcomes) showed lowered stress to adjacent discs as a result of spinal fusion compared with no intervention, as well as more even load distribution to the anterior column compared with existing traditional, rigid metallic rods and screws.

Clinician comments

“Helping to alleviate the stress is important as clinical studies have demonstrated adjacent segments to a fusion tend to wear out more quickly, which can necessitate additional surgical procedures down the road,” said Jean-Charles Le Huec, M.D., Ph.D., Chief of Spine Unit and Chairman of Department of Orthopaedic and Traumatology at Bordeaux University Hospital.

On sagittal balance, Dr Le Huec opined; “A spine (which is) “instrumented” in an unbalanced posture will result in an unsatisfactory surgery outcome. During surgery it is important to have enough curvature choices in rods that will allow me to follow the specific sagittal profile of my patient.”

US status

The product is not available for market in the United States at this time.

Source: Medtronic Inc