Pure-Vu system receives CE Mark

1st March 2018

Enaie Azambuja

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Datasheet

Motus GI Holdings, Inc. has 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(k) clearance from the FDA and is currently being introduced on a pilot basis in the U.S.

“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,” said Mark Pomeranz, CEO of Motus.

“We believe the Pure-Vu System has the potential to improve clinical outcomes while significantly reducing costs, particularly in our initial target market of difficult-to-prep in-patient colonoscopy.

While there are 30 million colonoscopy procedures performed annually worldwide, nearly 4 million of these procedures are performed for in-patients where reliance on conventional purgative-based bowel preps remains a serious challenge and leads to delayed diagnoses, extended hospital stays, and other increased costs due to repeat procedures and readmissions.”

Peter D. Siersema, MD, PhD, Professor of Endoscopic Gastrointestinal Oncology at the Radboud University Medical Center, Nijmegen, The Netherlands, and Medical Advisor of Motus, commented, “I believe the Pure-Vu System has tremendous potential to provide physicians with an easy-to-use device that enables a quality exam for patients, especially those who experience difficulty with the prep, and may minimise the possibility of a repeat procedure. The Pure-Vu System has the potential to make a real difference for patients undergoing a colonoscopy and may be an important tool in addressing colorectal cancer and other serious GI disorders.”