GI Windows said 6-month data from a small study of its incisionless anastomosis system showed the safety and efficacy of the device, which uses self-assembling magnets delivered via endoscope to create an opening between loops of the small bowel.
West Bridgwater, Mass.-based GI Windows said the device is designed to allow a portion of ingested food to move from the beginning of the small bowel to its end. Two endoscopes deploy the magnets in the proximal and distal ends of the small bowel, where they assemble into a pair of rings that are then coupled, trapping a portion of the the bowel walls to create an opening. Once anastomosis is achieved, the magnets release and are expelled naturally, GI Windows said.
The study followed 10 obese patients with a mean body mass index of 41 (4 had Type II diabetes and 3 were in the pre-diabetic range). Enteral diversion was safely achieved in all patients and the devices were expelled without incident, the company said.
All patients experienced significant reductions in HbA1c and fasting blood glucose levels at 6 months; among the pre-diabetic patients, HbA1c levels were reduced from a mean baseline of 6.1% to 5.25% and fasting blood glucose levels decreased from 119 mg/dl to 105 mg/dl. For the Type II diabetes cohort, HbA1c decreased from a mean baseline of 7.8% to 6.0%, with a decrease in fasting blood glucose levels from 177 mg/dl to 111mg/dl, GI Windows said.
The mean weight loss for all patients was approximately 28 pounds (12.9 kg), representing a 10.6% decrease in total weight.
“Based on this study’s findings, we believe the dual-path enteral diversion, created with the IAS system, may be a viable treatment option for obese patients living with Type II diabetes,” president & CEO James Wright said in prepared remarks. “Durability of effect, with non-surgical delivery, is at the core of the GI Windows value proposition. We are pleased with the results we are seeing at 6 months and look forward to presenting 12-month data with the self-assembling magnets in an upcoming publication.”
“Type II diabetes is a global pandemic and non-surgical treatment options are needed to effectively help the millions of patients manage this chronic condition,” added study investigator Dr. Evžen Machytka of the Czech Republic’s Ostrava University Hospital. “The results from this 6-month study are promising and suggest that the IAS, which relies on mechanisms of action proven in surgical approaches, has the potential to markedly reduce HbA1c, fasting blood glucose levels, and weight in obese patients with Type II diabetes. These findings warrant further investigation of the IAS technology.”
Here’s a video animation of the Gi Windows device:
