Lumendi said today it launched its DiLumen endolumenal interventional platform endoscope sleeve after winning CE Mark approval in the European Union for the device.
The Buckinghamshire, U.K.-based company said its DiLumen EIP is a non-sterile, single-use sleeve designed to fit over standard endoscopes to stabilize the devices in the large intestine.
Lumendi touted that the device has already been used in more than 400 procedures, and has been the subject of three clinical studies, the results of which are slated to be published later this year.
“Receiving approval to apply the CE mark in Europe is critical to Lumendi’s overall global strategy to open markets around the world to continue improving endoscopic interventions and migrating many gastrointestinal surgeries to less invasive endolumenal procedures. To make the DiLumen EIP platform available across the EU, we are building a team to support our distributors in Europe in both marketing and clinical application,” CEO Dr. Peter Johann said in a prepared statement.
In May, Lumendi said it won FDA 510(k) clearance for its DiLumen IS endolumenal interventional scissors, now indicated for cutting, dissecting and cauterizing tissue within the digestive tract during endoscopic procedures.