In colonoscopies performed in the study, the missed adenoma rate (AMR) was significantly lower when GI Genius was used compared to non-IA-assisted colonoscopy (15.5% vs. 32.4%; p-value 1. The study further found that the false negative rates, when a GI Genius-assisted colonoscopy detected one or more adenomas after an initial standard colonoscopy did not, were much lower than those from non-AI-assisted colonoscopies (6.8% vs. 29.6%) negative indicates that patients with an initial standard colonoscopy where no adenoma was detected were later found to have at least one adenoma during a second AI-assisted colonoscopy.
“We know colonoscopy is the gold standard for colon cancer screening and this study unequivocally demonstrates that AI technology can help doctors better detect polyps during the procedure,” said Dr. . Austin Chang , MD, MPH, medical director of the gastrointestinal business, which is part of Medtronic’s medical-surgical portfolio. “As a gastroenterologist, I worry about missed polyps because about half of all post-colonoscopy colorectal cancer cases can be attributed to not catching them during the index colonoscopy. 2.3 The impact of missed polyps could ultimately mean the difference between life and death when you consider that 90% of colon cancer patients can beat it when caught early.” 4
“These results highlight the value of artificial intelligence in increasing the detection of precancerous polyps in colonoscopy,” noted Douglas K.Rex , MARYLAND, MAGE, President, American Society of Gastrointestinal Endoscopy. “The goal of most colonoscopies is to prevent patients from getting colon cancer. So the more help I get to find polyps, the better. I have an adenoma detection rate very high but in my experience there are times when GI Genius has identified polyps that I might otherwise have missed.
The findings confirm main results of the DECECT study from November 2021 that AMR and polyp absence rate (PMR) improve significantly when GI Genius is used during colonoscopy. The study was funded by Cosmo Pharmaceuticals, the developer and manufacturer of Medtronic’s GI Genius system.
“This study highlights that the GI Genius System better helps working physicians detect polyps and lesions,” said Michael Wallace , MD, MPH, John C. Andersen Professor of Medicine at the Mayo Clinic, who led the study. “I couldn’t be more proud of the work we’ve done in partnership with Medtronic to bring disruptive technology to market that improves colorectal cancer screening and potentially saves lives.
The study (clinicaltrials.gov ID number: NCT03954548) was conducted at eight centers across the United States, Italy and the UK in teaching hospitals and community clinics. Study subjects included men and women aged 45 or older undergoing colorectal cancer screening or surveillance colonoscopy. Overall, 249 subjects were randomized (1:1) into the study, of which 230 subjects completed the study and were included in the analysis, undergoing two consecutive colonoscopies which were randomly assigned in the study. order in which they were performed: one with GI Genius and one colonoscopy with white light endoscopy.
Medtronic is the exclusive worldwide distributor of the GI Genius module which obtained De Novo clearance from the U.S. FDA on April 9, 2021 . In addition to United States the GI Genius module is available in Europe and select markets in Asia , Australia and the Middle East .
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Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s periodic reports filed with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
2 Zhao S, Wang S, Pan P, et al. Magnitude, risk factors, and factors associated with adenoma failure rate during tandem colonoscopy: a systematic review and meta-analysis. Gastroenterology 2019;156:1661-1674.e11
3 Robertson, DJ; Lieberman, DA; Winawer, SJ; Ahnen, DJ; Baron, JA; Schatzkin, A.; Cross, AJ; Zauber, AG; Church, TR; Lance, P.; et al. Colorectal cancers soon after colonoscopy: a multicohort pooled analysis. Gut 2014, 63, 949–956.
4 National Cancer Institute. Statistical facts about cancer: colon and rectal cancer. National Cancer Institute website. http://seer.cancer.gov/statfacts/html/colorect.html . Accessed February 7, 2017 .
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