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|Medtronic Receives Expanded Indications of the VERTEX® Reconstruction System|
Now FDA Cleared for Lateral Mass and Pedicle Screw Fixation in the Posterior Cervical Spine
DUBLIN - Feb. 16, 2015 - Medtronic plc (NYSE: MDT), today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for expanded indications of the VERTEX® Reconstruction System. The new clearance for the VERTEX® family of products allows for lateral mass and pedicle screws to be used as a form of fixation to treat various pathologies occurring in the posterior cervical spine, making it one of the first FDA-cleared systems available in the United States for use of screws at C1-C7.
"Broadening the VERTEX® Reconstruction System's indication beyond current upper thoracic screw fixation displays Medtronic's commitment to provide surgeons with the most innovative and effective surgical treatment options with the goal of improved patient care," says Dr. Vincent Traynelis, neurosurgeon at RUSH University in Chicago, IL. "This clearance opens up new opportunities for collaboration with medical device companies such as Medtronic to create a sound foundation on which we can advance current techniques, create new solutions, and deliver the next level of care to our patients."
"Our commitment to spine surgery goes beyond procedural innovation. As an industry leader, Medtronic is also focused on improving patient care through areas like advocacy for access to needed therapies and world-class medical education," said Doug King, president of the Spinal business and senior vice president of Medtronic. "Medtronic led the way in the pursuit of posterior cervical screw clearance nearly a decade ago, when we applied for and received FDA cervical screw clearance for our AXIS® Fixation System, which became the predicate device for cervical multi-axial screw fixation that we have just obtained. Through perseverance and collaboration with the FDA, we are excited to have reached this milestone and see it become a reality for Medtronic, our physicians, patients and other industry partners. Medtronic can now partner with physicians and professional spine societies to provide the most productive educational experiences to further understand and enhance the various techniques for treating conditions in the posterior cervical spine. This achievement is an exciting time for the spinal industry, and we are thrilled to be a part of the advancement in procedural innovation and portfolio expansion."
About the VERTEX ® Reconstruction System
Product Indications and Risks
Potential risks of the VERTEX® Reconstruction System include, but are not limited to: loosening, disassembly, bending, and/or breakage of components.
About Medtronic's Spinal Business
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.