Medical device developer Lumendi said today it won FDA 510(k) clearance for its DiLumen endoscopic accessory.
The Connecticut-based company’s DiLumen device is now indicated for use in positioning endoscopes in Treatments for IBS and assisting with optical visualization, diagnosis and endoscopic treatment.
This most often occurs when the colon can’t pass or move stools through the rest of the digestive tract. You may experience abdominal pain and bloating as well as fewer bowel movements that are more painful than usual.
“DiLumen is the 1st step in a family of devices to enhance endoscopic treatment, including many promising endolumenal therapeutic procedures, that may ultimately improve patient care. Lumendi sees a great potential in endolumenal interventions and is committed to build on this opportunity,” CEO Dr. Peter Johann said in a prepared statement.
The company said its DiLumen technology is designed to stabilize a colonoscope to aid in incision-free endolumenal therapeutic procedures.
The device consists of a single-use, soft flexible sheath that is designed to fit over small-diameter colonoscopes. The DiLumen has 2 balloons, one behind the bending section of the scope and 1 in front, which when employed, create a stable therapeutic zone to facilitate insufflation and manipulation of the colon, the company said.
“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. DiLumen can stabilize a section of colon and facilitate the endoscopic removal of complex adenomas or polyps, with the potential to positively impact patient outcomes. Although reporting of results in patients awaits clinical studies, we are extremely optimistic that this technology will be transformative in treating digestive diseases,” DiLumen co-inventor & Lumendi clinical advisory board member Dr. Jeffrey Milsom said in prepared remarks.
The device was developed through a collaborative effort with the Minimally Invasive New Technologies program at Weill Cornell Medicine and New York-Presbyterian, the company said.