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Medtronic gets FDA nod for Two-Level Prestige LP Cervical Disc procedures

Press releases may be edited for formatting or style | July 18, 2016

Risks of the Prestige LP Disc include, but are not limited to: development of new nerve or spinal cord compression or pain; allergic reaction to implanted material; or bone formation (including heterotopic ossification) that may reduce spinal motion or result in a fusion, either at the treated or at adjacent levels.

The low profile Prestige LP Disc has a ball-and-trough design and moves in a range of motions, including bending, rotation, and translation. The disc is made of titanium ceramic composite which provides improved wear resistance in combination with the mechanical, biocompatible, and imaging properties of the base titanium alloy. The device is MRI conditional at 1.5 and 3.0 Tesla and is now available in a smaller 5mm height.

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About Prestige LP Cervical Disc
The Prestige LP Cervical Disc is indicated in skeletally mature patients for reconstruction of the disc from C3-C7 following discectomy at one level or two contiguous levels for intractable radiculopathy (arm pain and/or a neurological deficit) with or without neck pain, or myelopathy due to abnormality localized to the level of the disc space and at least one of the following conditions confirmed by imaging (CT, MRI, X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height as compared to adjacent levels. The Prestige LP Disc is implanted using an anterior approach. Patients should have failed at least 6 weeks of non-operative treatment or have had the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of continued non-operative management prior to implantation of the Prestige LP Disc.


About Medtronic's Spine Division
We shape spine surgery for the better - delivering smart procedures and therapeutic biologics. As a global leader, we partner with other healthcare stakeholders to accelerate innovations that can improve surgical efficiencies and help create better outcomes for more patients.

About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world's largest medical technology, services and solutions companies - alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 85,000 people worldwide, serving physicians, hospitals and patients in approximately 160 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

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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