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FDA gives green light to MINT technology to treat colonic lesions

Building on the license they received from Cornell in 2014, Lumendi has secured FDA clearance for DiLumen (the MINT technology formally known as ESP).

The Dilumen is an endoscopic accessory, which is intended to help with positioning an endoscope in the large intestine and includes a single-use, soft flexible sheath that fits over standard and small-diameter colonoscopes. It utilizes two balloons – one behind the bending section of the colonoscope and the other in front of the tip – to help create "therapeutic zones" that allow for better visualization of lesions.

These zones are created after the balloons are deployed and inflated in a patient's intestine. The device helps stretch out the intestinal wall and straighten folds and bends, aiding in visualization. Upon the conclusion of the procedure, the balloons are deflated and removed with the colonoscope.

As one of the original inventors, Dr. Jeffrey Milsom, co-director at MINT has been involved in the development of the technology over a number of years. When talking about the recent developments Dr. Milsom said: 

“DiLumen’s use during flexible colonoscopy is a major technical advance in a field that has previously been defined by laparoscopic and open surgical procedures. DiLumen can stabilize a section of colon and may make it easier to remove complex adenomas or polyps, with the potential to positively impact patient outcomes.  Although reporting of results in patients awaits clinical studies, we are extremely confident that this technology will be transformative in treating digestive diseases.”

Following on from the approval of Dilumen, Lumendi plans to rollout the device nationwide in 2017 and will continue working with MINT to develop a suite of related products that will further enhance the possibilities in the new field of endolumenal surgery.

Read more about this exciting development at Lumendi and Medical Device Daily.