Motus GI has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its Pure-Vu Slim Sleeve, an extension to the Pure-Vu system for slim colonoscopes.
Image: Motus GI secures FDA approval to sell Pure-Vu slim-sleeve in US. Photo: Courtesy of yodiyim/FreeDigitalPhotos.net.
With the Pure-Vu Slim Sleeve design, Motus GI expects to gain access to full range of procedures in the colonoscopy market. The company estimates that about 30% of colonoscopy procedures are performed using slim colonscope.
Pure-Vu Slim Sleeve is claimed to have the same cleansing performance as the standard Pure-Vu Sleeve. The two versions work with the same Pure-Vu workstation control system. The Pure-Vu Slim Sleeve was designed to be compatible with smaller diameter and flexible slim colonoscopies.
Motus GI CEO Mark Pomeranz said: “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.”
The company also stated that it is focused on post-approval clinical trials and market development programs with US hospitals that are using the Pure-Vu System on a pilot basis, or in clinical trials such as the ongoing REDUCE study and upcoming EXPEDITE study, in preparation for commercial launch next year.
Pure-Vu system generates a pulsed vortex mixture of water and air to safely remove debris from the colon mucosa, while removing bowel contents. This clears the way for endoscopist to examine the patient.
The system includes a disposable component and a workstation controller. This disposable is now available in standard and slim versions will fit over a colonscope without interfering with the working channel.