Contrast Clearance Analysis Software Receives FDA 510(k) Clearance

Brainlab has announced U.S. Food and Drug Administration clearance of the Contrast Clearance Analysis methodology, developed in conjunction with Sheba Medical Center in Tel-Hashomer, Israel. The software analyzes magnetic resonance (MR) images to differentiate regions of efficient contrast clearance from regions with contrast accumulation in most cranial tumor patients to provide additional insight into post-treatment tumor characteristics.
 
“In conventional black and white MR images, it is often difficult to tell regions of high vascular activity apart from areas with damaged vasculature,” commented Yael Mardor, professor and chief scientist at The Advanced Technology Center of Sheba Medical Center. “Elements Contrast Clearance Analysis depicts contrast clearance efficiency of blood vessels in color to help clinicians better interpret the MR images and therefore support ongoing treatment assessment.”
 
Tissues that are highly vascularized and viable, such as active tumor tissue, are able to efficiently clear contrast agent within an hour of contrast injection. Conversely, regions consisting of damaged blood vessels, for example areas of necrosis, are unable to clear contrast agent as quickly, resulting in contrast accumulation. Based on this phenomenon, the software works by acquiring two magnetic resonance imaging scans—one at five minutes and another at least one hour after injection of a standard dose of contrast agent—and intelligently subtracting the first series from the second to clearly show the difference between contrast clearance and accumulation.
 
“Elements Contrast Clearance Analysis has become part of our neuro-oncology team’s standard clinical practice, as it is simple, robust and complements our existing workflows,” said Liam Welsh, M.D., consultant clinical oncologist at The Royal Marsden NHS Foundation Trust. “We have found every one of the scans analyzed for contrast clearance to be of assistance in our clinical decision-making. In the 30 percent of cases in which a subsequent decision was made to move forward with neurosurgery, we have observed a strong correlation between predicted and histologically observed viable tumor.”
 
Elements Contrast Clearance Analysis can provide critical insight to a multitude of specialties including radiation oncology, neurosurgery, neuro-oncology and neuroradiology.
 
Brainlab develops, manufactures and markets software-driven medical technology, enabling access to advanced, less invasive patient treatments. Brainlab’s technology powers treatments in radiosurgery as well as numerous surgical fields including neurosurgery, orthopedic, ENT, CMF, spine and trauma. Founded in Munich in 1989, Brainlab has over 11,800 systems installed in over 100 countries.