Ortho Kinematics obtains FDA 510k clearance for vertebral motion analysis system

15 August 2013 (Last Updated August 15th, 2013 18:30)

Ortho Kinematics, a US based diagnostic technology company, has received a 510K clearance from the US regulatory agency to expand the vertebral motion analysis (VMA) diagnostic technology to assess the cervical spine beyond the lumbar spine.

Ortho Kinematics, a US based diagnostic technology company, has received a 510k clearance from the US regulatory agency to expand the vertebral motion analysis (VMA) diagnostic technology to assess the cervical spine beyond the lumbar spine.

The VMA is a functional diagnostic test for the spine that uses fluoroscopy to capture the spine in motion, producing patient-specific graphs for each vertebral level.

Ortho Kinematics' CEO, Paul Gunnoe, noted that for many lumbar patients, VMA testing has made the difference in getting the right diagnosis to successfully treat unrelenting, debilitating back pain.

"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," Gunnoe said.

The new diagnostic technology offers an alternative to the routinely prescribed method for the assessment of spinal instability.

Instability in the spinal region causes severe back and neck pain, and more than 500,000 spine fusion surgeries are performed in the US every year.

The clinical studies also demonstrated the technology's ability to detect spinal instability in patients that may otherwise be difficult to assess using existing methods, enabling doctors to prescibe required treatments.

Spine surgeon Dr David Lee, who used the VMA lumbar system, noted that the VMA has been the only test capable of providing the evidence demanded by insurance companies to approve coverage for lumbar surgery.

"With the new cervical system, I can now offer this valuable option to my neck pain patients as well," Dr Lee said.

The company plans to launch the VMA system across the country by early 2014.