CLEVELAND, OH, October 21, 2019 — A large complex sigmoid polyp in a 62-year-old male patient was successfully removed in a 60-minute procedure without surgical intervention using DiLumen C2, a second-generation endoscopic dual balloon colon stabilization accessory that employs two 6mm working channels that accommodate several flexible therapeutic instruments designed to efficiently retract and dissect tissue. The endolumenal procedure was performed October 1, 2019 by Emre Gorgun, MD, Director of Endolumenal Surgery Center; Lower GI, Colorectal Surgery at The Cleveland Clinic in Cleveland, Ohio.
Previously, on August 29, 2019, the first successful case at Cleveland Clinic using DiLumen C2 was completed by Dr. Gorgun when a large complex polyp in the distal sigmoid, 18cm from the anus was removed from a 72-year-old woman with a narrow sigmoid. A frozen section was found to have negative margins, so a laparoscopic colectomy was unnecessary. Additionally, on September 24, 2019, Dr. Gorgun used the DiLumen C2 to remove a very large, recurrent polyp, 10 cm from the anus, in a 90-minute procedure from a 60-year-old male patient.
“These three patients were released from the hospital the day of the procedure, which would not have occurred were they to have had surgery,” said Peter Johann, CEO of Lumendi. “The growing, extensive use of DiLumen and now DiLumen C2 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, which will increase safety and patient recovery time as well as significantly reduce costs,” he added.
In addition to the DiLumen C2, Dr. Gorgun used several DiLumen accessories to easily remove the polyp, including the DiLumen Ig™ Endolumenal Interventional Grasper and the DiLumen Is™ Endolumenal Interventional Scissors. The Ig is a flexible endoscopic tool intended to grasp and manipulate tissue within the digestive tract under direct endoscopic visualization. The Is is a monopolar electrosurgical device for cutting, dissecting, and cauterizing tissue within the digestive tract.
Endolumenal intervention is a procedure performed within a hollow organ (like the gastrointestinal tract) using techniques such as retraction, dissection, and suturing, under endoscopic control. It is different from laparoscopic surgery — which saw rapid adoption in the 1990s — in that it accesses the targeted lesion for therapeutic treatment through a natural orifice (such as the anus), takes place entirely within the lumen without the need for incisions, and may involve the removal of diseased tissue via the natural orifice. As a result, endolumenal intervention preserves the patient’s anatomy and can significantly help increase patient safety, reduce the need for general anesthesia, increase the number of patients eligible for treatment, significantly shorten hospital stays (often to same day), reduce financial costs, and improve patient outcomes. While there are potential complications with any procedure, they are likely to be less significant with endolumenal intervention than with traditional or laparoscopic surgery.
The DiLumen C2 was developed by Lumendi in collaboration with the Minimally Invasive New Technologies (MINT) program at Weill Cornell Medicine and New York-Presbyterian Hospital. It is similar in design to the DiLumen EIP™, which has been used in more than 1,000 procedures across the U.S. and Europe. Both devices have two balloons for creating a stabilizing therapeutic zone inside the colon during endolumenal interventions. The DiLumen C2 now incorporates two 6 mm diameter tool channels, which accommodate two independent flexible articulating hand instruments.