Lumendi reports that it has received FDA 510(k) clearance for DiLumen EZ¹, a single-use, disposable endotherapy device for endoscopic mucosal resections (EMR) and difficult colonoscopies. The new, more cost-effective design, based on the long-standing success of the DiLumen EZ-Glide platform, has been modified and streamlined.
“The DiLumen EZ¹ device will meaningfully enhance our product portfolio by meeting more procedure specific needs for complex polyp resections which are conducted through EMR. Globally, EMR procedures represent the majority share of the over one million polyp resections conducted, annually,” said Dr. Peter Johann, Chief Executive Officer of Lumendi, Ltd.