FDA Clears Expanded Use for New Spinal Instability Test
Austin, Texas-based Ortho Kinematics Inc., a diagnostics company focused on spine imaging informatics, has been granted 510K0 clearance by the U.S. Food and Drug Administration to expand its VMA (vertebral motion analysis) system beyond the lumbar spine, so that the system can be available for cervical spine (neck) assessments as well.
The VMA system is intended as an alternative way to assess spinal instability. A 2009 paper published by Seminars in Musculoskeletal Radiology referenced the traditional checklist point system to assess spinal stability for each of the cervical, thoracic, and lumbar spines, calling it one of the best-recognized systems to date. VMA attempts to replace that. Spinal instability is a condition that very often results in severe back and neck pain, and is the number one most common primary diagnosis driving the more than 500,000 spine fusion surgeries done in the US each year.
According to Ortho Kinematics, VMA and has been shown in clinical studies to identify spinal instability that may be difficult to detect. As a result, VMA testing can help doctors identify a very common and treatable pathology that may be difficult to detect with the currently available test.
“For many lumbar patients, VMA testing has made the difference in getting the right diagnosis to successfully treat unrelenting, debilitating back pain,” said Paul Gunnoe, CEO of Ortho Kinematics. “With the clearance of the cervical VMA system, we are very happy to now offer this same opportunity to patients with neck problems as well.”
“I have seen for myself cases where the VMA has been the only test capable of providing the evidence demanded by insurance companies to approve coverage for lumbar surgery,” said David Lee, M.D., a spine surgeon user of the VMA lumbar system. “With the new cervical system, I can now offer this valuable option to my neck pain patients as well.”
VMA testing is currently available at a select set of spine surgery centers in the United States, and a large scale national roll-out is scheduled for early 2014.