Westport-based medical device provider Lumendi LLC has filed for U.S. Food and Drug Administration (FDA) 510(k) clearance for DiLumen EZ, a single-use, disposable endotherapy device intended for endoscopic mucosal resections (EMR) and difficult colonoscopies.
“EMR represents the majority share of polyp resection procedures worldwide, with over 1 million cases annually,” said Dr. Peter Johann, CEO of Lumendi.
Lumendi has also filed for FDA 510(k) clearance of a second device, DiLumen C, which is designed to facilitate complex polyp resection in the colon. According to the company, C”™s design offers a single working channel that accommodates an atraumatic grasper, which provides more direct tissue manipulation and traction and can improve enbloc dissection of precancerous and non-invasive cancerous polyps, a procedure known as endoscopic submucosal dissection.
“In addition, based on our success impacting therapeutic procedures in the colon and using our current technology, we have recently started a development program in upper GI interventions that we expect will lead to less invasive and less costly procedures with equal or better outcomes,” Johann added.
Photo: The DiLumen EZ, courtesy of Lumendi.
