Yes. The Pure-Vu® System is commercially available in various regions of the United States. With a commitment to provide dedicated support to customers as they integrate the System into their facilities, MOTUS^GI is currently limiting its focus and resources to select geographic regions.

The Pure-Vu® System received CE Mark in February 2018; however, MOTUS^GI efforts are currently focused on commercialization in the United States. Commercial activities in Europe are expected to start in 2020/2021.

MOTUS^GI is currently utilizing a direct sales force for the Pure-Vu® System commercialization efforts in the United States.

Yes. Pure-Vu® can be used for both inpatient and outpatient settings.

A number of major medical centers across the United States are currently using the Pure-Vu® System to clean poorly-prepped colons. For more information, please contact a MOTUS^GI representative.

At present, MOTUS^GI is not actively looking for additional clinical trial sites. However, if you have interest in participating in an upcoming clinical trial, please contact a MOTUS^GI representative. The clinical team assesses clinical needs and identifies appropriate partners for each study.

In three multi-center studies and one single-center study, patients presenting with an inadequately prepped colon (as determined by the Boston Bowel Preparation Scale) became adequately prepped for colonoscopy after cleansing with the Pure-Vu® System.

BBPS Rating Before and After the
Use of the Pure-Vu® System

To date, more than 600 procedures have been performed globally with the Pure-Vu® System.

Three perforations have been reported with the Pure-Vu® System to date. – In the first case, the patient was laparoscopically repaired and sent home within 12 hours. There have been no long-term complications reported. In the second case, the perforation may have occurred during attempted retroflexion, which is known to elevate such risks particularly in a narrow anatomy. In the third instance, the perforation was in an 80-year-old woman and occurred around the sigmoid flexure. These three instances are the only reported adverse events associated with use of the Pure-Vu® System worldwide.

Perforations are identified as precautions within the Pure-Vu® IFU and are consistent with the associated risk for a standard colonoscopy.

In cleansing mode, the Pure-Vu® System has an air flow of 0 cc in low mode, 1100 cc/min in medium, and 1350 cc/min in high mode; and the irrigation water flow has a maximum flow of 645 cc/min for all settings, but on average runs at 530 cc/min.

The amount of fluid used to cleanse the colon can fluctuate based on the level of dirtiness. However, on average, procedures use ~1L of fluid.

No. Colonoscope working channel remains patent so standard therapeutic procedure can be performed.

Yes. Use of the Pure-Vu System does not change your ability to insufflate with CO2. The majority of insufflation in a Pure-Vu procedure is CO2. The air emitted from the Pure-Vu device represents only a fraction of the gas in the lumen. Rapid absorption of CO2 should still take place during and after the procedure. I have not had physicians note discomfort or delay from the air in procedures.

No. The internal and external sensors deliver a constant air flow. The internal airflow measured by the Pure-Vu® System is used to speed up or slow down the suction pumps.

Yes. Physicians have found benefit and success with utilizing the Pure-Vu® System during the water exchange and water immersion techniques. MOTUS^GI is currently undergoing a single-center study to better assess the utility of our system in that application.

MOTUS^GI is committed to assisting its customers before, during and after Pure-Vu® System procedures. In addition to a robust inservice program for physicians, nurses and technical staff, MOTUS^GI provides hands-on support until customers are comfortable and proficient users of the System. Additionally, an intuitive Helpful Hints guide and instructive video are available for ongoing loading and unloading reference.