Motus GI Holdings, a medical technology company, has received CE mark approval for its 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(k) clearance from the U.S. Food and Drug Administration ("FDA") and is currently being introduced on a pilot basis in the U.S.
Motus CEO Mark Pomeranz said: “Receiving CE mark approval for the Pure-Vu System is a notable achievement as we work to expand the awareness of the benefits of the Pure-Vu System in key European markets over the next 24 months.
“CE mark approval enables us to continue to work with expert clinical thought leaders in Europe and begin to lay the foundation for future commercial expansion into Europe.
n 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 (“UEG”) Week conference in Fira Gran Via, Barcelona.
Results from the 47-patient study showed that the Pure-Vu System significantly increased the number of subjects with an adequate cleansing level (BBPS >= 2 for all 3 colon segments) 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.
The Pure-Vu® System is a 510(k) U.S. Food and Drug Administration cleared medical device indicated to help facilitate the cleaning of a poorly prepared colon during the colonoscopy procedure.
The device integrates with standard colonoscopes to enable cleaning during the procedure while preserving standard procedural workflow and techniques. The Pure-Vu System has received CE mark approval in Europe.