Motus GI receives European mark approval for Pure-Vu System
Motus GI announced that it has received European CE mark approval for its flagship product, the Pure-Vu System. The Pure-Vu System works with standard colonoscopes to help facilitate the cleaning of poorly prepped colons during the colonoscopy procedure, while preserving standard procedural workflow and techniques. The Pure-Vu System has previously received 510 clearance from the FDA and is currently being introduced on a pilot basis in the U.S. In November 2017, Motus reported positive results from its most recent European clinical study evaluating the performance of the Pure-Vu System in cleansing a poorly prepared colon at the 25th United European Gastroenterology Week conference. Results from the 47-patient study showed that the Pure-Vu System significantly increased the number of subjects with an adequate cleansing level from 19.1% at baseline to 100% after using the Pure-Vu System. Mean post-treatment BBPS score was 9 vs. 3 prior to Pure-Vu System use. Motus expects to continue to involve select European clinical centers in post-approval clinical trials of the Pure-Vu System it plans to conduct during the next 12 months and beyond.