DiLumen +DR Dynamic Retraction System Improves Endoscopists’ Ability to Dissect and Ultimately Resect Polyps Without Surgical Intervention
WESTPORT, CONN, June 11, 2019 — Connecticut-based medical device innovator Lumendi, LLC has launched its DiLumen +DR Dynamic Retraction System, unveiling it at the 2019 Digestive Disease Week (DDW) in San Diego and this month’s American Society of Colon and Rectal Surgeons (ASCRS) in Cleveland.
The DiLumen +DR is a new feature of the fore balloon assembly to help facilitate tissue manipulation for easier dissection and resection of polyps without the need for surgical intervention. The DiLumen +DR consistently provides effective tissue retraction, continuous tissue tension, and superior visualization of submucosal tissue planes enabling precise dissection. In addition to being used to create traction in ESD, the +DR System can be attached to a large pedunculated polyp via a detachable snare to ‘pull’ the polyp aside and expose the stalk.
According to Dr. Peter Johann, CEO of Lumendi, Ltd., “This modification to DiLumen has the potential to revolutionize tissue manipulation during both ESD and EMR. Current methods of retraction for ESD are clunky at best. Some involve anchoring a spring to a clip or using floss and a clip to create counter traction along the oral side of the polyp. Unlike the DiLumen +DR, these other procedures involve significant skills to master, and provide limited capabilities.”
Lack of proper traction and tissue manipulation has long plagued advanced endoscopists and colorectal surgeons. The DiLumen +DR has suture loops attached to the DiLumen’s fore balloon assembly. An endoscopic clip can then be simultaneously attached to the suture and the mucosal edge of a polyp during resection. Because the DiLumen fore balloon can be moved back and forth, doctors can now provide continuous and controlled traction to the tissue, which will enhance their ability to lift and dissect and ultimately resect polyps.
“The new logo quickly and easily conveys how DiLumen +DR revolutionizes polyp resection,” said Eric Coolidge, Vice President, Marketing, Lumendi LLC. “The visual of the bridge is an architectural depiction of dynamic retraction in action and was designed by world-renown architect Santiago Calatrava to demonstrate lift and traction in a similar manner as DiLumen +DR would work in a lumen.”
The DiLumen + DR is part of the DiLumen Endolumenal Interventional Platform (EIP), a non-sterile, single-use, close fitting sleeve that fits securely over a standard endoscope to stabilize it in the large intestine and facilitates use of the endoscope for optimal visualization, diagnosis, tissue manipulation and treatment. It is the first device from the Endolumenal Interventional Platform based on Lumendi initiative to migrate many gastrointestinal surgeries to endolumenal procedures.
Lumendi reports that more than 900 therapeutic procedures by more than 50 endoscopists and colorectal surgeons have been completed with its DiLumen™ EIP technology, continuing to demonstrate the safety, high performance and therapeutic benefits of the DiLumen. These procedures are in addition to those in its first-in-human study completed in October 2017. The DiLumen™ EIP, which received FDA 510(k) clearance to market in December 2016, has been commercially available in the United States since May 2017 and in Europe since July 2018, when it received CE Mark.
With recent regulatory approvals in Europe, Lumendi has conducted successful procedures with clinicians in many EU countries including Germany, France, Italy, Spain and the U.K. Lumendi has added distribution in those countries and continues to expand in others. The first procedures with DiLumen in Asia were successfully performed recently at Chinese University of Hong Kong.