Incision-less Anastomosis System – First data from IAS self-assembling magnets

New therapy is first of its kind with endoscopic delivery and the promise to achieve long-term benefits comparable to metabolic surgery.

The six-month results of the first-ever clinical study evaluating the endoscopic creation of a dual-path enteral diversion using the GI Windows’ Incision-less Anastomosis System (IAS) were announced at Digestive Disease Week 2016 (DDW), in San Diego, CA. The data support the safety and efficacy of GI Windows’ IAS as a treatment option for Type 2 diabetes in obese patients.

According to the company, this technology enables an endoscopic (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.

The technology

GI Windows has created a novel technology designed to create the same anastomosis performed in a surgical procedure, but with the lowered costs and invasiveness of an endoscopic (or non-surgical) intervention.  The GI Windows procedure is intended to be done on a same-day, outpatient basis, and with no surgical incisions.

The company’s innovation creates an anastomosis using a slender, linear device, that can be loaded in the channel of a standard endoscope or a thin conduit, such as a catheter or needle.  As the device is deployed from the scope or catheter, it self-assembles to form a large, octagonal shape.

When two of these devices are deployed in adjacent hollow organs, the devices join together and form a compression anastomosis, without the need for staples, sutures, or surgical access (Figure 1).

Figure 1: Two standard endoscopes are used to access the small bowel. Self-forming magnets are deployed from the working channel of each endoscope. (Credit GI Windows)

The GI Windows invention leverages the science already demonstrated with compression-based anastomotic techniques. This approach uses the body’s own healing processes to remodel tissue between two structure to form an anastomosis between two structures.  With the GI Windows technology, this anastomosis can be large, patent, and created without surgical access.

The dual-path enteral diversion was created with a flexible endoscope, as smart, magnetic devices are deployed from the scope and self-assemble in the small bowel. 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 (Figure 2).

Figure 2: The devices are connected to creat a compression anastomosis. When the anastomosis fully-formed, the devices are passed. A treatment path is created, bypassing a portion of the small bowel. (Credit GI Windows)

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 visualize the anastomosis.

Outcomes

The 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 ten obese patients, with a mean BMI41. 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 percent to 5.25 percent 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 percent to 6.0 percent at six months, with a decrease in fasting blood glucose levels from 177 mg/dl to 111mg/dl.

Evžen Machytka

“Type 2 diabetes is a global pandemic and non-surgical treatment options are needed to effectively help the millions of patients manage this chronic condition,” said Dr Evžen Machytka, Ostrava University Hospital, a study investigator. “The results from this six-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 2 diabetes. These findings warrant further investigation of the IAS technology.”

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 percent decrease in total weight loss.

“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 2 diabetes,” said James Wright, President and CEO of GI Windows. “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 six months and look forward to presenting 12-month data with the self-assembling magnets in an upcoming publication.”