FDA Clears TomTec’s MRI 2-D Cardiac Performance Analysis

 

November 1, 2012

November 1, 2012 — TomTec Imaging Systems GmbH announced U.S. Food and Drug Administration (FDA) 510(k) clearance for its new 2-D Cardiac Performance Analysis MR (2-D CPA MR) software solution for magnetic resonance imaging (MRI).

2-D CPA MR is a vendor-independent software solution for the quantification of myocardial function with cardiac MR cine images. 2-D CPA MR presents a new method to analyze myocardial deformation from routine CMR images, which have been acquired as part of a conventional cardiovascular MR examination. No time consuming tagging is necessary with the software.

Based on innovative feature-tracking technology, 2-D CPA MR calculates regional and global velocity, displacement, strain and strain-rate parameters.

With minimal user interaction, the manual trace of a single endocardial contour serves as initial pattern from which the system tracks the displacement of myocardial structures over the length of a complete heart cycle. The software tracks endo- and epicardium, and describes left ventricular deformation in terms of longitudinal, radial and circumferential components.

“2-D CPA MR provides incremental information regarding left ventricular deformation and enhances the diagnostic possibilities. With 2-D CPA MR, even a comprehensive strain analysis can be fully integrated into your clinical routine workflow,” said Rolf Baumann, TomTec's vice president of clinical products and innovations.

For more information: www.tomtec.de