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Motus GI Holdings, Inc., (“Motus GI” or the “Company”), a medical technology company dedicated to improving clinical outcomes and enhancing the cost-efficiency of colonoscopy, announced that it has received special 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Pure-Vu® Slim Sleeve, a compatible extension to the Pure-Vu® System for slim colonoscopes.
The Pure-Vu® Slim Sleeve design enables Motus GI to now gain access to the full range of procedures in the colonoscopy market as we estimate, through consultation with colonoscope manufacturing companies, approximately 30% of procedures are performed with a slim colonoscope. Pure-Vu® Slim Sleeve has the same cleansing performance as the standard Pure-Vu® Sleeve and both versions work with the same Pure-Vu® workstation control system. The Pure-Vu® Slim Sleeve has been designed to be compatible with smaller diameter and more flexible slim colonoscopes with additional enhancements to the Company’s low friction lubricious coating technology to aid in navigation through the colon.
“Having Pure-Vu® compatible with slim colonoscopes will be critically important for patients with complex anatomy which can happen quite often in the inpatient setting,” noted Tamas Gonda, M.D. from Columbia University Medical Center in NY. “From my in vitro testing experience with the Pure-Vu® Slim Sleeve on a slim colonoscope, the device had excellent handling and navigation performance.”
Mark Pomeranz, CEO of Motus GI, commented, “Receiving this special 510(k) clearance from the FDA for the Pure-Vu® Slim Sleeve is an important milestone that will allow physicians to use the Pure-Vu® System on slim colonoscopes which we estimate, through consultation with colonoscope manufacturing companies, are currently used in approximately 30% of procedures and growing in the United States. Pure-Vu® Slim Sleeve was designed with the same stringent standards used for the Pure-Vu® System. We are excited to have this new product available for clinical use in the coming weeks. We expect that it will increase the number of patients that can benefit from the Pure-Vu® System, which we believe has the ability to rapidly cleanse the colon and overcome the high rates of insufficient bowel prep in the inpatient setting that can lead to delayed diagnosis, repeat preps and procedures, as well as longer hospital stays.”
“We remain focused on our post-approval clinical trials and market development programs with leading U.S. hospitals that are utilizing the Pure-Vu® System on a pilot basis, or in clinical trials such as the ongoing REDUCE study and our upcoming EXPEDITE study, in preparation for our 2019 commercial launch. We are establishing strong working relationships with physician champions and their staff within leading institutions that we believe can become long-term important customers for our products. We look forward to further advancing the development and adoption of both the Pure-Vu® System and Pure-Vu® Slim Sleeve, which we believe will improve quality of care and reduce healthcare costs by reliably and predictably moving patients through the hospital system to a successful examination,” added Mr. Pomeranz.
Pure-Vu® generates a proprietary pulsed vortex™ mixture of water and air to safely remove debris from the colon mucosa while simultaneously evacuating the bowel contents, clearing the way for the endoscopist to perform a quality examination even when the patient does not or is not able to complete a successful prep on his or her own. The Pure-Vu® System consists of a disposable component and a workstation controller. The disposable, now available in standard and slim versions, fits over a colonoscope without interfering with the working channel. Motus GI’s clinical trials, such as the ongoing REDUCE study and its upcoming EXPEDITE study, are designed to evaluate the Pure-Vu® System’s ability to rapidly cleanse the colon intra-procedurally to allow physicians to better visualize, diagnose and, if necessary, treat the colon using standard techniques and tools.
For Further Information
More on the GI endoscopy market in the U.S. can be found in a series of reports published by iData Research entitled the U.S. Market Report Suite for Gastrointestinal Endoscopic Devices. The suite covers reports on the following markets: GI flexible endoscopy, capsule endoscopy, virtual colonoscopy, endoscopic retrograde cholangiopancreatography (ERCP), stenting and dilation, biopsy, specimen and foreign-body removal, hemostasis, enteral feeding, anti-reflux, and Barret’s Esophagus.
The iData report series on GI endoscopic devices covers the U.S. and 15 countries in Europe including Germany, France, the United Kingdom (U.K.), Italy, Spain, Benelux (Belgium, Netherlands and Luxemburg), Scandinavia (Finland, Denmark, Sweden and Norway), Portugal, Austria and Switzerland. Reports provide a comprehensive analysis including units sold, procedure numbers, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment. To find out more about GI market data or procedure data, register online or email us at [email protected] for a U.S. Market Report Suite for Gastrointestinal Endoscopic Devices brochure and synopsis.