Motus GI’s Pure-Vu EVS System Earns FDA Nod

Endoscopy solutions maker Motus GI Holdings has gained U.S. Food and Drug Administration (FDA) 510(k) clearance for the second generation of its Pure-Vu EVS System for visualization during colonoscopy. The new system aims to improve on the previous generation with improved setup speed, enhance navigation abilities for difficult anatomy, and build on cleansing capabilities.
 
All of these features seek to rapidly overcome challenges of a colon poorly prepared for colonoscopy.
 
“My experience with the Pure-Vu Gen2 system has allowed me to treat and diagnose patients who otherwise would have been delayed. The new Pure-Vu EVS ergonomics are much better than the current version. The oversleeve and the scope feel much more integrated and it is easier to torque the scope, offering significantly improved navigation,” Houston gastroenterologist Scott Larson, M.D. told the press.
 
“Pure-Vu EVS is much easier to use, and will be more physician and technician friendly. The set-up is significantly simpler, and the slimmer, more flexible design felt like I didn’t have an oversleeve on my scope,” added fellow Houston gastroenterologist Neha Mathur, M.D.
 
Pure-Vu integrates with both standard and slim colonoscopies, irrigating the colon to evacuate debris for a better-quality exam. The latest generation of Pure-Vu allows on-demand bedside loading and a smaller workstation footprint, as well.
 
Motus GI aims to launch Pure-Vu EVS in the first quarter of this year.
 
“We believe our Pure-Vu EVS system now offers physicians the right tool to help address challenging colonoscopy procedures. The development and innovation we’ve implemented in Pure-Vu EVS is the result of listening to valuable feedback from leading physicians and clinical staff that have utilized our Pure-Vu platform. This FDA clearance of Pure-Vu EVS is expected to allow a greater number of physicians and hospitals to bring this important technology to their patients,” commented Tim Moran, Motus GI CEO. “We believe the Pure-Vu EVS enhances every aspect of our system from speed of set-up to procedural ease-of-use, while also offering optimized navigation, handling and cleaning capacity. Additionally, the new EVS oversleeve is able to be loaded on a ‘dirty’ scope in the procedure room, an important new capability that will allow broader utilization of Pure-Vu to help physicians complete difficult cases and better visualize the colon mucosa. We have also implemented an improved manufacturing cost structure that we believe better positions the company to broaden commercial utilization, improve margins and establish distribution relationships in more cost sensitive global markets over time.”