Motus GI said today it won CE Mark approval in the European Union for its flagship Pure-Vu system designed to clean poorly-prepped colons during colonoscopies.
Approval was supported by positive results from a 47-patient European clinical study of the Pure-Vu system in cleaning poorly prepared colons, which showed an increase in the number of adequately cleansed patients from 19.1% at baseline to 100% after use.
“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. 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 medical advisor Dr. Peter Siersema of the Netherlands’ Radboud University Medical Center said in a prepared statement.
The Fort Lauderdale, Fla.-based company said it has previously received FDA 510(k) clearance in the US, and is introducing the product on a pilot basis.
“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. 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,” CEO Mark Pomeranz said in a press release.
Late last month, Motus GI said it closed an initial public offering worth $18 million for its Pure-Vu system for intra-colonoscopy cleaning.
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston.