Lumendi today announced it received FDA 510(k) clearance for two of its single-use, disposable endotherapy devices.
The Westport, Connecticut-based company received FDA clearance for its DiLumen EZ¹ single-use, disposable end-therapy device for endoscopic mucosal resections and difficult colonoscopies. Its DiLumen C¹ was also cleared for use in complex polyp resection in the colon and rectum via endoscopic submucosal dissection (ESD).
“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,” Lumendi CEO Peter Johann said in a news release.
Lumendi’s DiLumen C¹ has a single working channel that accommodates an atraumatic grasper for more direct tissue manipulation and traction. The use of the device and the grasper improves curative removal of precancerous and non-invasive cancerous polyps during ESD.
”Since 2017, clinicians in the U.S., EU, the UK and Asia, have completed over 4,000 procedures with the commercially available DiLumen EZ Glide. These newest devices, when combined with the increasing market adoption of DiLumen EZ Glide, will accelerate Lumendi’s continued vision to shift procedures away from invasive gastrointestinal surgeries, towards endoluminal procedures with lower complication rates, little to no hospital stays and very minimal recovery times,” Johann said. “In addition, based on our success impacting therapeutic procedures in the colon and using our current technology, we will look to expand our development program into upper GI interventions, which we expect will lead to better patient outcomes.”