“The KineGraph VMA allows for a more nuanced understanding of how each level of the spine is functioning by providing an expanded set of vivo spine biomechanical data.”
Abstract
Texan Spine diagnostics company Ortho Kinematics has reportedly received 510(k) clearance from the U.S. Food and Drug Administration for the KineGraph VMA™ (Vertebral Motion Analyzer) system. The KineGraph VMA system is designed to improve a test routinely prescribed by spine surgeons—the flexion/extension x-ray. The company has the bold goal of replacing the current method of detecting spinal dysfunction and aims to become the standard for spine functional testing.
Background
Flexion/Extension x-rays have remained the standard for quantifying spine function for over 60 years. The standard test provides only a rough approximation of spine function because it compares measurements, taken from X-ray images, of patients standing upright versus bending backward, forward, and sideways. The aim is for the KineGraph to replace the end-range x-ray method of spine functional testing. In the U.S., end-range x-rays are currently ordered 1.6 million times per year for pre-fusion patient work-ups and follow-up testing.
What is Kinegraph VMA?
The technology for measuring the motion between the vertebrae outperforms the current end-range x-ray method by standardising and automating each of its basic steps: (1) patient bending, (2) image acquisition, and (3) image analysis.
Key to the KineGraph VMA innovation are the patented Motion Normalizer™ devices, which provide powered passive trunk bending in either a standing or lying down configuration. As the Motion Normalizer bends the trunk through a set range of motion, hundreds of fluoroscopic images of the spine are captured at standardized trunk bending angles. Image recognition software locates the vertebrae on each frame. The intervertebral angle (IVA) is plotted as a function of the degree of trunk bending, creating a KineGraph™ plot for each vertebral level.
In this way the KineGraph VMA allows surgeons to view videos of vertebral motion that cover the entire range of spine bending instead of comparing just two x-ray “snapshots”. In addition, a much more expansive set of biomechanical measurements are produced and overlaid on the video images. By delivering a more complete and actionable diagnostic dataset, the company claims its KineGraph VMA can support more informed treatment decisions without increasing the radiation exposure to the patient.
Clinician comments
Dr. Antonio Castellvi, a spine surgeon with clinical experience using the KineGraph VMA, says “Spine biomechanics are very complex, and in many cases flexion/extension x-rays simply don’t provide enough data. The KineGraph VMA allows for a more nuanced understanding of how each level of the spine is functioning by providing an expanded set of vivo spine biomechanical data.” Dr. Castellvi continued, “In the future, this may open the door to new ways of factoring spine biomechanics into our surgical decisions.”
Company comments
Adam Deitz, CEO of Ortho Kinematics, says “We believe there is an opportunity to fundamentally improve the way spine pathology is assessed. Spine surgeons lack some functional diagnostic tools in comparison to other surgical specialties, such as cardiovascular surgeons, who have benefitted for decades from advanced functional tests like electrocardiogram (EKG), stress testing and angiography. With this 510(k) clearance, we can now begin to bridge this gap.”
The company expects to make the KineGraph VMA commercially available in the United States starting in February, initially limiting access to a select group of the largest U.S. spine specialty hospitals.
Source: Ortho Kinematics Inc.
