MEMPHIS, Tenn.–(BUSINESS WIRE)–Continuing a stream of recent advancements for stabilization of the spine, Medtronic, Inc. (NYSE: MDT) today announced both the release of its CD HORIZON® SOLERA™ Spinal System in the U.S. and a limited market release in Japan. This product launch is part of the CD HORIZON® family of fixation devices, designed to provide spinal stabilization and correction as an adjunct to fusion in patients suffering from painful and function-limiting disorders of the middle and lower back.
“This launch builds on other recent advances in spinal fixation, including the releases of the VERTEX SELECT™ Reconstruction System and the TSRH® 3Dx™ Spinal System, and serves as a foundation enabling Medtronic to continue to deliver meaningful advances in spine care.”
The CD HORIZON® SOLERA™ Spinal System is designed to be compatible with Medtronic’s proprietary minimally invasive technologies, known as MAST™. It also is unique in that it is integrated with Medtronic’s surgical navigation and imaging systems and the NIM-ECLIPSE™ neuromonitoring system. This allows for decreased exposure to radiation for hospital staff, and improved accuracy of device placement to avoid injury to nerves. The system accommodates multiple rod material options, allowing choice in rod flexibility and strength to match the demands of a variety of spinal conditions. Additionally, smaller implants may provide the advantages of increased room for bone graft required for fusion, and reduced impingement on the facet joints. The facet joints are the small stabilizing joints located at the intersection of adjacent vertebrae.
In addition, Medtronic is working to improve patient care and hospital efficiencies by offering a complete solution for electronically tracking specific implants to individual patients. The CD HORIZON® SOLERA™ Spinal System implants are equipped with VERIFYI™ Implant Tracking System technology, which is similar to barcode technology, and provides device quality and utilization-related data for customers in a manner that meets anticipated FDA requirements for unique device identification (UDI).
“The launch of the CD HORIZON® SOLERA™ Spinal System is a key step in renewing our global fixation business, bringing new innovation to the market and extending our industry-leading portfolio of spinal therapies,” says Doug King, Vice President and General Manager of the Spine business at Medtronic. “This launch builds on other recent advances in spinal fixation, including the releases of the VERTEX SELECT™ Reconstruction System and the TSRH® 3Dx™ Spinal System, and serves as a foundation enabling Medtronic to continue to deliver meaningful advances in spine care.”
About the CD HORIZON® SOLERA™ Spinal System
The CD HORIZON® SOLERA™ Spinal System is Medtronic’s fifth generation spinal fusion system and is cleared to treat patients with degenerative disc disease, spinal stenosis, fracture, dislocation, failed previous fusions, tumors and, uniquely, adolescent idiopathic scoliosis. Extending the unmatched clinical history of more than twenty-five years and 500,000 patients represented by the CD HORIZON® product line, the CD HORIZON® SOLERA™ Spinal System offers the important combination of lower profile pedicle screw implants and performance. Enabling features include the OSTEOGRIP® thread pattern for enhanced fixation at the bone-implant interface, and a patented “closure mechanism,” or means of connecting to a variety of implants in a streamlined fashion. Notably, the system accommodates multiple rod material options and gives surgeons and hospitals an array of choices to treat a diverse set of spinal conditions.
Risks associated with such a system include loosening, disassembly, bending, and/or breakage of components, fracture, microfracture, resorption, damage, or penetration of any spinal bone. Selection of the proper size, shape, and design of the implant for each patient is crucial to its safe use. A successful result is not always achieved in every surgical case. The safety and effectiveness of this device has not been established for use as part of a growing rod construct when used in pediatric cases, and is only intended to be used when definitive fusion is being performed at all instrumented levels.
About the Spine Business at Medtronic
The Spine 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 Spine business collaborates with world-renowned surgeons, researchers and innovative partners to offer state-of-the-art products and technologies for neurological, orthopaedic and spinal conditions. Medtronic is committed to developing affordable, minimally invasive procedures that provide lifestyle friendly surgical therapies. More information about the company and its spinal treatments can be found at www.medtronicspinal.com and its patient-education Web sites, www.back.com, www.iscoliosis.com, www.maturespine.com and www.necksurgery.com.
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.
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.