Lumendi Reports First Incisionless Appendectomy Using Double-Balloon Endolumenal Interventional Platform
WESTPORT, CONNECTICUT --
Connecticut-based medical device innovator Lumendi, LLC reports the first endoscopic appendectomy using its DiLumenTM Endolumenal Interventional Platform (EIP). A patient underwent the purely endoscopic endolumenal appendectomy to remove a lesion previously identified at the appendiceal orifice. The patient reported no post-procedure pain, was discharged home from the endoscopy unit, resumed regular physical exercises and returned to work the morning after the appendectomy. Sergey V. Kantsevoy, MD, PhD, FJGES, Director of the Therapeutic Endoscopy at Melissa L. Posner Institute for Digestive Health and Liver Disease at Mercy Medical Center, Baltimore, Maryland, performed the procedure.
Appendectomies are traditionally performed through open or laparoscopic surgery, requiring an incision (or several punctures) of the abdominal wall. This can result in incisional pain, an increased risk of postoperative incisional hernias, and delays returning to work or resuming physical activity. Unlike previously reported Natural Orifice Transluminal Endoscopic Procedures (NOTES) transvaginal or transgastric appendectomy, access to the appendix was carried out via the patient’s cecum (first part of the colon), rather than through a gastric or vaginal wall incision.
To facilitate this less invasive endoscopic approach, Dr. Kantsevoy used a double balloon endolumenal interventional platform (DBEIP) consisting of a flexible overtube with two manually inflatable balloons: one behind the endoscope tip, the other with the ability to be advanced beyond the scope tip. On the significance of this DBEIP case, Dr. Kantsevoy said that “the stability and dynamic traction provided by DBEIP makes purely endoscopic endolumenal appendectomy technically feasible. It also eliminates the need for incisions or punctures of the abdominal wall, lessening the risk of post-surgical incisional hernias and intraperitoneal adhesions.”
According to Dr. Kantsevoy, “Endoscopic endolumenal appendectomy is less invasive than traditional surgical, laparoscopic, transvaginal or transgastric appendectomy. This novel endoscopic procedure will reduce post-procedure pain, will eliminate the need for hospital admission, and will assure an earlier return to work and regular physical activities, as compared with surgical, laparoscopic, transvaginal and transgastric appendectomy.”
“This new intervention demonstrates the options provided by the DiLumen platform,” said Dr. Peter Johann, Chairman & CEO of Lumendi. “Our focus is now on expanding the scope of DiLumen and DiLumen C2 beyond complex polyps, pre-cancerous lesions and non-invasive early cancers of the lower GI tract.”
Lumendi’s DiLumen EIP is an endolumenal device with a double-balloon design that aims to safely improve the navigation of the endoscope through the bowel, creating a stabilizing therapeutic zone inside the colon during endolumenal interventions, and minimizing potential mucosal injury. The device is compatible with most standard colonoscopes, aides the advancement of colonoscopes and endoscopic suturing devices through the colon, improves scope stability and provides dynamic multidirectional retraction during endolumenal colonic interventions. Clinicians have used DiLumen in more than 1,300 procedures across the U.S. and Europe.