Motus GI said today that it won FDA 510(k) clearance for its Pure-Vu slim sleeve as part of its Pure-Vu system, intended for use during slim colonoscopies.
With the clearance of the Pure-Vu slim sleeve, Motus GI said that the Pure-Vu system is now cleared for the full range of procedures in the colonoscopy market, with an estimated 30% of procedures performed with a slim colonoscope.
The Pure-Vu slim sleeve was designed to be compatible with smaller diameters and more flexible slim colonoscopes and features additional enhancements to its low friction lubricious coating tech to aid in navigation, the Ft. Lauderdale, Fla.-based company said.
“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. From my in vitro testing experience with the Pure-Vu Slim Sleeve on a slim colonoscope, the device had excellent handling and navigation performance,” Dr. Tamas Gonda of New York’s Columbia University Medical Center said in a prepared statement.
“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,” CEO Mark Pomeranz said in a press 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. 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.
In March, Motus GI said that it won CE Mark approval in the European Union for its flagship Pure-Vu system designed to clean poorly-prepped colons during colonoscopies.