August 26, 2021 - Lexington, Mass. - FUJIFILM Medical Systems U.S.A., Inc., a leading provider of endoscopic and endosurgical imaging technology, today announces the commercial launch of the ELUXEO® 7000X System, a new video imaging technology developed to enable real-time visualization of hemoglobin oxygen saturation (StO2) levels in tissue using laparoscopic and/or endoluminal imaging.
The ELUXEO 7000X is an upgrade to the company’s ELUXEO® Endoscopic Imaging System, and will be unveiled at the annual Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) conference, held August 31 – September 3 at Sands Expo Convention Center in Las Vegas Nevada. The ELUXEO Endoscopic Imaging System revolutionized endoscopic visualization when it was introduced to the U.S. market in 2018 with its proprietary 4-LED Multi-light technology. The ELUXEO 7000X System employs 5-LED technology to enable this enhanced imaging capability.
Enabling the visualization and analysis of StO2 levels helps surgeons more accurately identify potentially ischemic tissue, better positioning surgeons to address and prevent tissue necrosis.
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Today’s standard for visualizing tissue perfusion is to leverage fluorescent imaging using indocyanine green (ICG) dye- a method in which an injectable dye circulates through the bloodstream and is excited using near-infrared light. Physicians then use that excited dye to identify blood flow. Fujifilm’s innovation was developed to address potential limitations resulting from ICG:
Intravenous dye injections are not required prior to imaging.
GI tract observation time frame can be extended as liver filtration of ICG dye is no longer a factor.
In addition, ICG does not allow physicians to detect potential ischemic tissue during endoluminal procedures, making the ELUXEO 7000X the only product on the market to enable this visualization via StO2 measurements.
The technology was granted “breakthrough device” designation by the U.S. Food and Drug Administration (FDA) in September, 2020, and received 510(k) clearance from the FDA on June 30, 2021.
The endosurgical research team at Fujifilm has been working closely on clinical usage of the technology with key opinion leaders from top medical centers in the United States and Japan.
"I find the ELUXEO 7000X System to be a game changing technology in the fields of MIS and endosurgery,” says Paul Curcillo, MD, FACS, Department of Surgical Oncology, Division of Minimally Invasive Surgery, Fox Chase Cancer Center. “The ability for real-time assessment of StO2 allows me to identify tissue necrosis without factoring in time restrictions and the need for consumables. In addition, we can use it in any laparoscopic case we are doing with our existing ELUXEO endoscopic imaging system.”