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Motus GI receives CE mark for colonoscopy device

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The European Commission awarded a CE mark to the Pure-Vu System, a device used in standard colonoscopies to help facilitate the cleaning of poorly prepped colons, according to a press release issued by the manufacturer Motus GI.

The device previously received 510(k) clearance from the FDA in 2016, and is being introduced in the United States on a pilot basis.

“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,” Mark Pomeranz, CEO of Motus said in the press release. “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.”

The Pure-Vu System’s efficacy in cleansing a poorly prepped colon was tested in a recent European clinical study that included results from 47 patients. According to the findings presented last November at the 25^th United European Gastroenterology Week conference, the device increased the number of patients with an adequate cleansing level from 19.1% to 100%, according to the press release.

“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 minimize the possibility of a repeat procedure,” Peter D. Siersema, MD, PhD, professor of endoscopic gastrointestinal oncology at the Radboud University Medical Center, Nijmegen, The Netherlands, and medical advisor of Motus, said in the press release. “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.”

Motus said it plans to continue post-approval trials over the course of 2018 and beyond.

Disclosures: Pomeranz is employed by Motus, and Siersema is a medical advisor for Motus.