Lumendi’s endoscopic surgery accessory approved by FDA

Westport medical device manufacturer Lumendi has received U.S. Food and Drug Administration 510(k) clearance for its DiLumen C2.

The device is a second-generation endoscopic surgery accessory that can be used to ensure complete positioning of an endoscope in the large intestine and assist with optical visualization, diagnosis and endoscopic treatment. Lumendi’s first surgical accessory, the DiLumen, was approved in late 2016.

Fitting over a standard endoscope, it allows surgeons better stabilization and visualization within the intestine, facilitating endolumenal procedures in the removal of large or complex polyps. The company said the C2 is similar in design to its Endolumenal Interventional Platform [EIP] as both feature two balloons used for creating a stabilizing therapeutic zone inside the colon during endolumenal interventions.

The C2 incorporates two 6mm diameter tool channels, which accommodate two independent flexible articulating hand instruments. The C2, along with other Lumendi flexible-articulating instruments, can create a unique therapeutic platform that will further enable clinicians to perform complex procedures completely within the colon without open surgery, according to the firm.

“To date, we have completed over 350 procedures with the commercially available DiLumen EIP with no serious adverse events,” Lumendi CEO Dr. Peter Johann said. “Three clinical studies have also been completed, further demonstrating safety and cost effectiveness.”

Those studies are expected to be published in the near future, he said.