Ortho Kinematics KineGraph Vertebral Motion Analyzer System Receives FDA Clearance

Ortho Kinematics KineGraph Vertebral Motion Analyzer System Receives FDA Clearance

Ortho Kinematics Receives FDA 510(k) Clearance for KineGraphVMA System

Innovative technology bridges diagnostic gap hampering spine surgeons for decades

AUSTIN, Texas – January 10, 2012 — Ortho Kinematics‚ a private company focused on revolutionizing spine motion analysis, announced receiving 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.

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 KineGraph VMA involves patented refinements that allow 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 KineGraph VMA can support more informed treatment decisions. This can all be accomplished without increasing the radiation exposure to the patient.

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.”

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.

About Ortho Kinematics

Ortho Kinematics is a privately held spine diagnostics enterprise committed to the idea that spine motion matters. The company is working with a group of leading clinicians, researchers and developers who are passionate about leveraging spine biomechanical data to improve the diagnosis and treatment of spine disease. Please visit us on the web at www.orthokinematics.com.

Technology Overview

The KineGraph VMA™ (Vertebral Motion Analyzer) is a functional diagnostic test for the spine that uses fluoroscopy to capture the spine in motion.

Key Features

Fast, non-invasive and radiation1 that has been reported in the medical literature to be comparable with the current standard of care (end-range x-rays)

Quantitative measurement and true functional test vs. fixed position end-range x-rays

Early testing indicates potentially improved diagnostic capabilities

Provides new insights for implant device design

Controlled patient positioning to reduce test variability

What it is

This technology for measuring the motion between the vertebrae outperforms the current end-range x-ray method by standardizing and automating each of its basic steps: (1) patient bending, (2) image acquisition, and (3) image analysis.

1 Patient Bending

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.

2 Image

Acquisition

As the Motion Normalizer bends the trunk through a set range of motion, hundreds of fluoro images of the spine are captured at standardized trunk bending angles.

Ortho Kinematics has received FDA clearance for its KineGraph Vertebral Motion Analyzer (VMA) system. The KineGraph VMA system is designed to standardize and automate the processes involved with flexion/extension X-rays, including patient bending, image acquisition and image analysis. Motion Normalizer devices provide powered passive trunk bending in either a standing or lying down configuration. Fluoroscopy images of the spine are then captured at standardized trunk bending angles. Image recognition software locates the vertebrae on each frame and the intervertebral angle is plotted as a function of the degree of trunk bending, creating a KineGraph plot for each vertebral level. From the press release:

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 KineGraph VMA involves patented refinements that allow 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 KineGraph VMA can support more informed treatment decisions. This can all be accomplished without increasing the radiation exposure to the patient.

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 : http://www.orthokinematics.com/media/press-release-0112.php

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