New clinical data of USGI Medical’s Incisionless Operating Platform demonstrated that surgeons can use Incisionless Operating Platform to durably reduce the size of the stomach pouch and stoma in Roux-en-Y Gastric Bypass (RYGB) patients who are regaining weight.
Clinical results from 116 patients presented at American Society of Metabolic and Bariatric Surgeons (ASMBS) Annual Meeting near Dallas, University of California, San Diego (UCSD) Medical Center surgeon Santiago Horgan, M.D. on Friday, June 26.
We believe this is the first data to confirm 12-month durability for gastric folds created without incisions, said Dr. Horgan, director of UCSD’s Center for the Future of Surgery and Center for the Treatment of Obesity. Invasive procedures to restore the anatomy to the original post-surgery proportions are too complicated for many patients. Surgeons have tried to perform restorative procedures through the mouth using other types of endoscopic instruments, however GI tissue is extremely resistant to change and it’s been difficult to show long-term durability of procedures utilizing endoscopic sutures or staples. USGI’s Expandable Tissue Anchors have allowed us to achieve a desired amount of durable reduction in the pouch and stoma size without any significant adverse events, filling a significant unmet medical need in this patient population.
Surgeons used USGI’s IOP in Restorative Obesity Surgery, Endolumenally (ROSE) to grasp tissue and deploy Expandable Tissue Anchors to create multiple, circumferential tissue folds around the stoma and inside the pouch. The endoscope provides visualization and procedure is performed entirely through the patient’s mouth.
Surgeons were able to place tissue folds in 112 of 116 (97%) patients. On average, surgeons placed six Expandable Tissue Anchor pairs in each of these 112 patients and reduced their mean stoma diameter by 50% and pouch length by 44%.
Twelve-month post-op endoscopies performed on 19 patients by Dr. Horgan confirmed the durability of the procedure. There were no significant complications associated with the procedure and most patients’ reported no or minimal pain.