Medtronic (NYSE:MDT) said today that it won an expanded indication from the FDA for its Vertex spinal fixation system, covering lateral mass and pedicle screw use in the posterior cervical spine.
Medtronic said the expanded indication makes it 1 of the 1st systems cleared in the U.S. for use of screws at vertebrae C1 to C7.
The Vertex system can now be used as an adjunct to fusion in the cervical spine from C1 to C7 and the thoracic spine from T1 to T3, according to a press release.
"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, Medtronic spinal president Doug King said in prepared remarks. "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. 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.”
“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," added Dr. Vincent Traynelis of Chicago’s Rush University. "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."