Westport-headquartered medical device developer Lumendi LLC has received U.S. Food and Drug Administration (FDA) 510(k) clearance for two new devices.
Clearance was granted for DiLumen EZ, a single-use, disposable endotherapy device for endoscopic mucosal resections (EMR) and difficult colonoscopies. Clearance was also granted for the DiLumen C, which is designed to facilitate complex polyp resection in the colon and rectum via endoscopic submucosal dissection.
Lumendi CEO Dr. Peter Johann stated the DiLumen EZ device will “meaningfully enhance our product portfolio by meeting more procedure specific needs for complex polyp resections which are conducted through EMR.” He added that 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.”
