Medtronic Announces CE Mark and European Launch of Compact CORNERSTONE-SR Alliance – Oct 03, 2013– Memphis, USA (Techreleased) – Medtronic, Inc. the world leader in spinal technology, announced today the CE Mark (Conformité Européenne) and the European launch of a new cervical cage system which expands the successful Compact CORNERSTONE-SR® platform of cages.
The Compact CORNERSTONE-SR® Alliance(TM) cage is compatible with existing spinal instrumentation and gives the surgeon a variety of implant options for different patient anatomies. The new Compact CORNERSTONE-SR Alliance System leverages knowledge gained when Medtronic acquired the German company Advanced Medical Technologies in mid-2012. The additional features now available include: four titanium fixation spikes, bevelled edge and side chamber. Compact CORNERSTONE-SR and Compact CORNERSTONE-SR Alliance are available for use across Europe. The implants are not commercially available or for distribution in the United States or its territories at this time.
Cervical cages are implants used to treat patients who suffer from a disc disease that affects the neck (cervical spine). When a spinal disc is diseased, it can shrink from its normal height, putting pressure on nerves and causing pain in the neck and arms. Compact CORNERSTONE-SR Alliance implant is designed to provide stability during spinal fusion, which involves joining two bones together, such as adjacent vertebrae. There are more than 44,000 cervical fusion procedures to relieve compression on the spinal cord or nerve roots performed in Europe each year.1 In the UK alone the NHS is believed to spend close to £500m on spinal surgery.2
The European launch of Compact CORNERSTONE-SR Alliance System coincides with the Eurospine congress held in Liverpool, UK this week. Speaking at Eurospine, Steve Swinson, Medtronic Vice-President Spinal & Biologics Western Europe and Canada comments on the new product introduction: “Anterior cervical spine surgeries remain commonplace and it’s important to bring innovation to this market. With the addition of the CORNERSTONE-SR Alliance cage to our cervical Interbody platform, Medtronic continues to answer the surgeon and hospital needs of today.”
About Compact CORNERSTONE-SR and Compact CORNERSTONE Alliance Cages
The Compact CORNERSTONE-SR and Compact CORNERSTONE-SR Alliance are anatomical cervical cages used to stabilize the spine and promote bone fusion following interbody fusion surgery in the cervical spine. Both implants are available in a variety of widths, heights and geometrics for adaptability to patient anatomy. The cages’ hollow design allows for in situ packing with autograft or synthetic bone substitute.
Possible Adverse Effects
Adverse effects may occur when the device is used either with or without associated instrumentation. The potential risk of adverse effects as a result of movement and non-stabilization may increase in cases where associated instrumentation is not employed. Potential adverse events include but are not limited to:
Early or late loosening or movement of the device(s).
Breakage of any or all of the components or instruments.