WESTPORT, CONN, OCTOBER 4, 2018 − Connecticut-based medical device innovator Lumendi, LLC reports that more than 500 therapeutic procedures by more than 40 endoscopists and colorectal surgeons have been completed with its DiLumen™ EIP technology, continuing to demonstrate the safety, performance and therapeutic benefits of DiLumen. These procedures are in addition to those in its first-in-human trial 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 established distribution in the UK and Italy and has conducted successful procedures with clinicians in each country. Professor James East, M.D. of John Radcliffe Hospital in Oxford, England, said he “found DiLumen gave me both the stability and tissue retraction necessary to facilitate a safe and complete removal of these complex polyps, preserving patients’ colon and rectum and saving them the possibility of having to endure a surgical resection.” Additional procedures have been completed in France and Germany and Lumendi will be adding distribution in those countries and others shortly. The first procedure with DiLumen in Asia was successfully performed recently at Chinese University of Hong Kong.
The DiLumen Endolumenal Interventional Platform (EIP) is 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 optical visualization, diagnosis, and treatment. It is the first device from the Endolumenal Interventional Platform based on Lumendi initiative to migrate many gastrointestinal surgeries to endolumenal procedures.
“The growing, extensive use of DiLumen validates our goal of shifting the paradigm for colon disease intervention from the traditional surgical approach to a truly minimally invasive one that utilizes novel endolumenal-based technology. This shift will increase safety and patient recovery time as well as significantly reduce costs,” said Dr. Peter Johann, CEO of Lumendi, Ltd.