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|Medtronic CD HORIZON BalanC™ Spinal System Launches Internationally with CE Mark|
Unique combination of materials and geometry provide surgeons new options for neutral stabilization spinal cases
Barcelona, Spain – March 21, 2012 – 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:
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
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
About the Spinal Business at Medtronic
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
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