Mar 21, 2012 –Barcelona, Spain — Medtronic, Inc. (NYSE: MDT) announced today the CE (Conformité Européenne) 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.
The announcement was made at the International Society for the Advancement of Spine Surgery (ISASS) in Barcelona.
The CD HORIZON BalanC™ Rod is a neutral stabilization rod with a unique combination of polyetheretherketone (PEEK) and silicone materials and geometry.
While computational analysis and mechanical testing are not indicative of clinical outcomes, analysis using these standard methods showed the following:
- The CD HORIZON BalanC™ Rod resulted in lower stress caused by a spinal fusion to the discs adjacent to the fused segments compared to no intervention.
- The fusion portion of the rod distributes load more evenly to the anterior column compared with existing traditional, rigid metallic rods and screws.
- 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.
Potential risks associated with the use of the device include, but are not limited to: disassembly, bending and/or breakage of any or all of the components, and tissue or nerve damage caused by improper positioning and placement of implants or instruments.
“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.
About Sagittal Balance
Sagittal balance of the spine is critical. Maintaining or restoring the lordosis, the natural curve of the lumbar, or lower part of the spine, is important to avoid mechanisms of compensation that will increase lumbar pain and stress on the lumbar-pelvic spine.
“A spine instrumented in an unbalanced posture will result in an unsatisfactory surgery outcome,” said Le Huec. “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.”
To create a construct that matches different patients’ balance profiles, the CD HORIZON BalanC™ Rod is offered in four different curvatures.
About CD HORIZON BalanC™ Rod
The CD HORIZON® BalanC™ Spinal 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. The product is not available for market in the United States at this time.
About the Spinal Business at Medtronic
The Spinal business, based in Memphis, Tenn., is the global leader in today’s spine market and is committed to advancing the treatment of spinal conditions. The Spinal business collaborates with world-renowned surgeons, researchers and innovative partners to offer state-of-the-art products and technologies for orthopaedic and spinal conditions. Medtronic is committed to developing affordable, minimally invasive procedures that provide lifestyle friendly surgical therapies