GI Windows Shows 6-Month Study Data on Non-surgical Procedure to Treat Type 2 Diabetes with Self-Assembling Magnets.
(C)2016 M2 COMMUNICATIONS
- US-based medical device company GI Windows, Inc. has presented six-month results of what it calls the first-ever clinical study evaluating the endoscopic creation of a dual-path enteral diversion using the company's Incision-less Anastomosis System at Digestive Disease Week 2016, in San Diego, California, the company said.
According to the company, the data support the safety and efficacy of GI Windows' IAS as a treatment option for Type 2 diabetes in obese patients.
For more than 20 years, studies have confirmed that obese patients with Type 2 diabetes can experience significant and lasting metabolic improvements through bariatric surgeries, such as the gastric bypass.
The GI Windows technology enables a non-surgical procedure that can divert a portion of ingested food from the proximal to distal small bowel, providing a less-invasive approach to achieve comparable long-term metabolic benefits as those seen in bariatric surgery.
This study reported on the safety and metabolic impact of a dual-path enteral diversion using GI Windows' Incision-less Anastomosis System. The procedure was performed on 10 obese patients, with a mean body mass index of 41.
Four patients had Type 2 diabetes and three more patients were in the pre-diabetic range.
The study found that the dual-path enteral diversion was safely created in all patients, and the IAS devices were expelled without incident.
At six months, investigators observed that all patients experienced significant reductions in HbA1c and fasting blood glucose levels.
For patients with pre-diabetes, HbA1c levels were reduced from a mean baseline of 6.1% to 5.25% at six months, and fasting blood glucose levels decreased from 119 mg/dl to 105 mg/dl.
Patients with Type 2 diabetes showed a decrease of HbA1c from a mean baseline of 7.8% to 6% at six months, with a decrease in fasting blood glucose levels from 177 mg/dl to 111mg/dl.
All patients had fasting blood glucose levels move from the diabetic or pre-diabetic range to the normal range at six months. The mean weight loss for all patients was approximately 28 pounds (12.9 kg), representing a 10.6% decrease in total weight loss.
The devices transform from a linear shape to an octagonal geometry and then couple to form an anastomosis -- a connection between two hollow or tubular structures or organs.
Coupled devices are eventually expelled naturally, leaving behind an anastomosis without residual foreign material.
Patients enrolled in the study were restricted to a two-week post-op liquid/soft diet, underwent an upper GI series to confirm anastomotic patency (the degree of openness or exposure) at two weeks post implant, and received follow-up endoscopies at two and six months to visualise the anastomosis.
GI Windows is a clinical-stage medical device company developing an incision-less anastomotic system that can be used to create non-surgical therapies to treat Type 2 diabetes.
The company's technology is designed to enable durable, intestinal bypasses to address chronic diseases, such as Type 2 diabetes and obesity, without the cost and invasiveness of surgical interventions.
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|Date:||May 24, 2016|
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