The FDA has issued 510(k) clearance to Motus GI Holdings Inc. for the commercialization of a novel device that is compatible with smaller diameter and more flexible slim colonoscopes with additional enhancements to Motus’ low friction lubricious coating technology to aid in navigation through the colon, according to a company press release.
“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,” Tamas A. Gonda, MD, of Columbia University Medical Center, said in the release.
Pure-Vu, according to the release, generates a mixture of water and air to remove debris from the colon mucosa while simultaneously evacuating the bowel contents, clearing the way for an endoscopist to perform an examination even if a patient fails to complete a successful prep on their own.
The Pure-Vu System consists of a disposable component, which fits over a colonoscope without interfering with the working channel, and a workstation controller.
“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,” Mark Pomeranz, CEO of Motus, said in the release.
“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,” Pomeranz added.