® today announced that positive results of a pivotal comparison study
of standard forward-viewing colonoscopy (SFV) and EndoChoice's Full Spectrum Endoscopy
™ System (Fuse™) were published in the March issue of The Lancet Oncology.
The study determined that standard forward-viewing colonoscopes missed 41% of adenomas (pre-cancerous polyps). The study showed that the Fuse™ Endoscopy System, equipped with multiple imagers that create a near-panoramic view, detected an additional 69% more pre-cancerous polyps than the standard forward-viewing colonoscopes.
"As the gold standard for colorectal cancer screening, standard forward-viewing colonoscopy still misses a significant percentage of pre-cancerous polyps due to inadequate visualization of the many folds and bends of the colon," said lead study investigator Ian M. Gralnek, MD, MSHS, FASGE, Chief of Hospital-Wide Ambulatory Care Services and Senior Gastroenterologist, Department of Gastroenterology, Rambam Health Care Campus, Haifa, Israel. "These study results confirm that Fuse is an important technological advancement in colorectal cancer screening that significantly improves visualization and has the potential to improve screening outcomes for many patients."
The multicenter international study, "Standard forward-viewing colonoscopy versus full-spectrum endoscopy: an international, multicenter, randomized, tandem colonoscopy trial
", compared 185 people who had same day, back-to-back tandem colonoscopies. In 88 patients who underwent standard forward-viewing colonoscopy (SFV) first, 29 adenomas were identified while Fuse found an additional 20 adenomas in a follow-up colonoscopy on those same patients. This means that standard colonoscopy (SFV) missed 41% of the adenomas in these patients. This dramatic miss rate by standard colonoscopy is a major concern for physicians and patients.
The study also showed there were 5 patients in whom standard colonoscopy failed to detect any adenomas, yet a follow-up Fuse colonoscopy discovered pre-cancerous polyps. As a result, SFV gave false negative impressions to 6% of patients, while patients who had a Fuse colonoscopy first did not have any false negative examinations. Dr. Gralnek said that "if a patient only gets screened every 10 years as currently recommended by international guidelines, such a high false negative rate with SFV colonoscopy is unacceptable".
Colonoscopy screening programs have been proven to save lives. "Detecting potentially cancerous polyps with a truly comprehensive examination is important," said Eric Hargis, CEO of the Colon Cancer Alliance
. "The only way to prevent colon cancer is to get screened and catch the disease early. Throughout the years we have achieved tremendous success in lowering the mortality rate associated with colon cancer as a result of advances in screening technology and public education programs."
"The results of this study support our greatest priority as physicians, which is to miss fewer pre-cancerous polyps and improve the quality of our colonoscopies," said Dr. Gralnek. "It is important for doctors and their patients to know the Fuse™ endoscopy platform is now available and has the ability to significantly increase adenoma detection rates," he continued. About Fuse™ Endoscopy System
The revolutionary Fuse™ Endoscopy System (Fuse™) allows clinicians to see more of the GI tract than ever before. While traditional endoscopes offer a limited field of view (no more than 170° for colonoscope or up to 150° for gastroscope), the Fuse endoscope system provides a significantly expanded field of view (330° for colonoscope; 245° for gastroscope). Multiple imagers make the near-panoramic view possible. Fuse™ projects the expanded view onto three screens instead of one, giving physicians previously unseen views, such as behind colonic and pyloric folds, and other difficult anatomy. LEDs illuminate the field adding longevity and durability beyond fiber optic illumination. Using a proprietary design, EndoChoice® engineers arranged all these components comfortably into the Fuse endoscope's distal tip. About EndoChoice®
Based in Atlanta, EndoChoice is a medtech company focused on the manufacturing and commercialization of platform technologies including devices, diagnostics, infection control and endoscopic imaging for specialists treating a wide range of gastrointestinal diseases. EndoChoice leverages its direct sales organization to serve more than 2,000 customers in theUnited States and works with 34 distribution partners world-wide. The Company was foundedin 2008 and has rapidly developed a proprietary product portfolio, which includes the revolutionary Full Spectrum Endoscopy™ System (Fuse™). 2013 marked the fourth consecutive year EndoChoice was recognized as one of the fastest growing companies in the U.S. by Inc. Magazine. To learn more, visit http://www.endochoice.com
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