Viatronix Virtual Colonoscopy Technology receives FDA approval for detection of colon cancer

Stony Brook 26 April 2004The results of a groundbreaking virtual colonoscopy study recently published in the December 2003 New England Journal of Medicine (NEJM) and American Journal of Roentgenology citing the Viatronix V3D-Colon system to be dramatically more reliable and accurate than other virtual colonoscopy systems led to its recent Food and Drug Administration (FDA) approval as a screening tool for detecting colon cancer.

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"This once more demonstrates that Viatronix is a pioneer in diagnostic medical imaging and ahead of its competition", stated Zaffar Hayat, President of Viatronix Inc. "Viatronix V3D-Colon is presently the only available product in the market to receive FDA clearance for the purpose of patient screening for detection of colon cancer, polyps, masses and other lesions. Based on the results as published in the prestigious NEJM, Viatronix V3D-Colon has proven to be equal or better than optical colonoscopy, empowering medical institutions to offer virtual colonoscopy to the general public. Virtual Colonoscopy is now clearly ready for prime time."

"After performing a direct comparison of three different virtual colonoscopy systems, we determined that only one system, the Viatronix system, was capable of a primary time efficient 3D reading, which I believe is necessary for sensitive detection of polyps", stated Perry J. Pickhardt, M.D., author of the armed services study, whose credentials include Staff Radiologist for the National Naval Medical Center, Assistant Professor of Radiology for the Uniformed Services University of the Health Sciences, and currently Associate Professor of Radiology at the University of Wisconsin Medical School. For polyps 8mm and greater, V3D-Colon outperformed optical colonoscopy, long considered the "gold standard" of colorectal cancer screening as reported in the clinical study published in NEJM.

The non-invasiveness of the V3D procedure is itself a benefit to patients, eliminating not only the physical discomfort of a conventional optical colonoscopy, but also the inherent risk of perforation of the colon walls. The Viatronix virtual colonoscopy requires no sedation, so patients can resume normal activities immediately after the short 15-minute procedure. Viatronix is the only systems on the market that offers a less harsh preparation by allowing the patients an alternative of a low residue diet because the system's software electronically removes any tagged stool remnants or liquid from the colon.

The benefits to physicians are equally remarkable, particularly when compared to other virtual colonoscopy systems in use. The Viatronix V3D system offers diagnosticians far greater work flow optimized capabilities for manipulating and analysing the scanned images with a high-resolution visualization system.

In addition, instead of simply using the automatically generated fly-through examination, the Viatronix software allows operators to manually interact, turn, zoom, and rotate the images at will in a "live" volume rendering environment, dramatically increasing the opportunity to locate and identify polyps. Because of that image manipulation, they are able to view the entire surface of the colon, see behind folds, as opposed to only 70 to 90 percent in "completed" optical colonoscopy cases. The Viatronix Software also offers a number of other intuitive tools that help improve physician efficiency and reduce false positive findings.

Read more on the results published in the December 2003 NEJM Armed Services Study in this VMW issue's articles:


Leslie Versweyveld

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