Medical devices maker Lumendi has secured approval from the US Food and Drug Administration (FDA) for its DiLumen EIP device modification to improve tissue retraction during therapeutic endoscopy.
DiLumen endolumenal interventional platform (EIP) is a non-sterile, single-use and close-fitting sleeve, which fits over a standard endoscope to stabilize it in the large intestine and facilitates use of the endoscope for better visualization, diagnosis, tissue manipulation and treatment.
The FDA has approved DiLumen EIP technology with suture loops placed in the skirt along the trailing edge of the fore balloon.
The device with modification will help improve tissue manipulation for easier dissection and resection of polyps without the requirement for surgical intervention.
DiLumen EIP, which is available in working lengths of 103cm, 130cm and 168cm, can offer stability and traction in any part of the colon.
The modification enables suture loops to be attached to the device’s fore balloon assembly, and an endoscopic clip can then be simultaneously attached to the suture and the mucosal edge of a polyp during resection.
Doctors can offer traction to the tissue, as the DiLumen fore balloon can be moved back and forth. It will help enhance their ability to lift and dissect and resect polyps.
In December 2016, the DiLumen EIP secured 510(k) clearance from the FDA, and is commercially available in the US from May 2017. It also secured CE mark approval in Europe.
DiLumen is said to be the first device from the platform based on Lumendi initiative to migrate various gastrointestinal surgeries to endolumenal procedures.
Lumendi CEO Peter Johann said: “This is an important step in Lumendi’s continued dedication to innovate our existing devices that facilitate endolumenal procedures for many gastrointestinal interventions.
“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.”
Based in Westport of Connecticut, Lumendi is engaged in the development, marketing and distribution of surgical tools and devices for minimally invasive gastrointestinal interventions.