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By Liz Hollis

Staff Writer

With an eye toward promoting minimally invasive procedures and treating colorectal disease within a patient's intestine, Westport, Conn.-based Lumendi LLC has scored a win at the U.S. FDA with its new device.

This week, the company reported that the agency has cleared the Dilumen endoscopic accessory, which is intended to help with positioning an endoscope in the large intestine.

The accessory 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.

Dilumen aims to help in the treatment of colonic lesions, such as polyps, reducing the need for open surgical or laparoscopic procedures. Eric Coolidge, vice president of marketing at Lumendi, confirmed that the company plans to roll out the device nationwide in May 2017.

Peter Johann, CEO of Lumendi Ltd., said the device represents a "first step in a family of devices to enhance endoscopic treatment," adding that the company sees "great potential in endolumenal interventions and is committed to build on this opportunity."

Help from MINT

Development of the accessory came about as a result of an agreement between the Minimally Invasive New Technologies Program (MINT) at Weill Cornell Medical College and New York- Presbyterian Hospital, which linked up with investors to establish Lumendi in 2014.

Originally prototyped at MINT, the endoluminal surgical platform saw further development and refinement at Lumendi ahead of a submission at the FDA. Lumendi holds an exclusive worldwide license from Cornell on the ESP platform and related ancillary products.

There are a number of advantages for this approach versus endoscopic procedures, especially as they typically are performed in older patients who have a more difficult time recovering from invasive procedures and the accompanying anesthesia.

Last year, MINT co-director Jeffrey Milsom touted another advantage of the proposed platform, noting that current offerings do not have the same level of stability. A problem with existing options is that the endoscope tip is difficult to control, thereby affecting the precision of surgery. "With this device, you can better control and manipulate the surgical environment inside the intestine," he added.

Further, Cornell researchers have estimated that ESP-enabled procedures will spare 200,000 patients each year from having to undergo invasive surgical procedures for difficult-to-treat polyps. In addition, the platform could help save the U.S. health care system more than $650 million a year.

Following the clearance, Milsom expressed further optimism. "Dilumen's use during flexible colonoscopy is an important technical advance in a field that has previously been defined by laparoscopic and open surgical procedures," he said. "Although reporting of results in patients awaits clinical studies, we are extremely optimistic that this technology will be transformative in treating digestive diseases," he added.

Work is not finished, however, as MINT plans to develop a series of products to enhance the ESP platform as it aims to boost the number of procedures that can be performed endolumenally. Among the proposed tools are flexible surgical instruments to help in the performance of complex surgical procedures within the intestinal channel. However, the program has stated that its goal is to establish a new field of endoluminal gastrointestinal surgery and has eyed therapeutic areas such as diverticular disease, stricture, intestinal fistulae, prolapse, volvulus, anastomosis leaks, and early cancers.

On its website, MINT has listed other products in its pipeline, including ESP+, which will aim to allow clinicians to deliver multiple surgical tools simultaneously into the therapeutic zone to perform advanced endolumenal surgical procedures. In addition, it is eyeing work on flexible articulating surgical tools to work with ESP+.

That said, Coolidge told Medical Device Daily that it was "premature" to discuss what's next in terms of product development on Lumendi's end; however, he did note that the company is eyeing partnerships. It also is looking to launch in other markets, starting with the European Union.

Lumendi estimated that there are about 1 million new colorectal cancer cases diagnosed each year globally. Polyps, which can be precursors to colorectal cancers, are missed up to 40 percent of the time during colonoscopies.

Published  December 14, 2016

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