Medtronic, Inc. (NYSE: MDT), today announced the European launch of the SOVEREIGN™ Spinal System.
The SOVEREIGN™ Spinal System is an intervertebral body (interbody) fusion device used to treat patients who suffer from degenerative disc disease affecting the lumbar spine. When a lumbar disc is diseased, it can lose height, compressing nerve roots and the spinal cord, causing pain in the lower back. The SOVEREIGN™ Spinal System is designed to stabilize the spine and promote bony fusion, which involves the joining of two bones together, such as adjacent vertebrae.
The SOVEREIGN™ Spinal System is an intervertebral body fusion device with internal screw fixation. The screws protrude through the interbody portion of the device and stabilize the vertebral body while preventing expulsion of the implant. The implant is lens-shaped with three holes for placement of titanium screws. The SOVEREIGN™ interbody device is intended to be used with the three titanium alloy screws which accompany the implant. If the physician chooses to use less than three, or none of the provided screws, then additional supplemental fixation for use in the lumbar spine must be used to augment stability. If the physician chooses to use screws with the implant, the accompanying cover plate must be used. This device is intended to be radiolucent and the interior space of the product is to be used with bone graft.
The SOVEREIGN™ Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via a laparoscopic or an open anterior approach.
The SOVEREIGN™ Spinal System incorporates technology developed by Gary K. Michelson, MD.
About the Spine Business at Medtronic
The Spine business is based in Memphis, Tenn. It is the global leader in today’s spine market and is committed to advancing the treatment of spinal conditions. The Spine business works with world-renowned surgeons, researchers and innovative partners to offer state-of-the-art products and technologies for neurological, orthopaedic, dental 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 treatment therapies 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.
About Medtronic
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, Minnesota, U.S.A. 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.
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