UK-based Lumendi has obtained the European CE-Mark for its DiLumen Endolumenal Interventional Platform (EIP) as an endoscope accessory.
The device is a non-sterile, single-use, close-fitting sleeve intended to enable complete positioning of a conventional endoscope in the large intestine and aid in optical visualisation, diagnosis and treatment.
Following the CE-Mark approval, Lumendi is set to commercially launch the device in the European Union (EU) market, for which the company is currently developing a distribution network.
The company said that it has already established distributors for Italian and British regions.
Lumendi CEO Peter Johann said: “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.”
DiLumen is the initial device under the Endolumenal Interventional Platform that is part of Lumendi’s aim to switch various gastrointestinal surgeries to endolumenal procedures.
An endolumenal approach is expected to minimise general anaesthesia requirement, allow incisionless approach, decrease complications found with open or laparoscopic surgery, shorten hospital stays and reduce costs.
DiLumen EIP consists of two balloons that, when deployed and inflated, stabilise the area in between them. This therapeutic zone (TZ) is said to also allow insufflation and manipulation of the tissue.
The device is said to have been used to perform more than 400 procedures in the US to date.