Current Technology | EndoPRO Solutions

Today’s non-surgical technology solutions address obesity but are hampered by limitations.

Intragastric Balloon (IGB)

Theory:

Inflated balloons in the stomach cause fullness (satiety) which diminishes food intake

Endoscopic Bariatric Therapries	Manufacturer	Description	FDA Approval
GASTRIC INTERVENTIONS
Orbera gastric balloon	Apollo Endosurgery Austin, TX	Single fluid-filled balloon Endoscopic placement & removal Filled with 400-700cc of saline	BMI 30-40 kg/m² Age 22 or older
ReShape integrated dual balloon system	ReShape Lifesciences San Clemente, CA	Two connected fluid-filled balloons Endoscopic placement & removal Each balloon filled with 375-450cc of saline	BMI 30-40 kg/m² with one obesity-related comorbidity Age 22-60
Spatz3 adjustable balloon system	Spatz Medical Great Neck, NY	Single fluid-filled balloon with a connecting tube for volume adjustment Endoscopic placement & removal Filled with 400-550cc saline 4. Volume adjusted down to 300cc or up to 800cc	Under FDA review
Obalon balloon system	Obalon Therapeutics Carlsbad, CA	Gas-filled balloon Swallowed with XR guidance and endoscopic removal Three balloons administered over 9-12 week period	BMI 30-40 kg/m² Age 22 or older
Aspiration therapy	Aspire Bariatrics King of Prussia, PA	26-French gastrostomy tube with 15cm fenestrated drainage catheter Endoscopic placement & removal Patients aspirate 25%-30% of ingested calories 30 minutes after meals	BMI 35-55 kg/m² Age 22 or older
Transpyloric shuttle	BAROnova Inc. Goleta, CA	A spherical bulb tethered to smaller cylindrical bulb Endoscopic placement & removal Located across the pylorus creating intermittent obstruction	Under FDA review

Data:

Obalon Therapeutics (formerly BioEnterics) had 3,600 patients with six months duration of IGB placement that had a mean weight loss of 32 lbs (12%).
Complications after first week include nausea & vomiting (9%), pain (5%), spontaneous deflation (4.2%) with (0.8%) and without obstruction (2.5%).

Theory:

Impermeable small bowel (intestine) membrane that prevents absorption of calories

Endoscopic Bariatric Therapries	Manufacturer	Description	FDA Approval
SMALL BOWEL INTERVENTIONS
Duodenal-jejunal bypass liner	GI Dynamics Boston, MA	60cm fluoropolymer liner anchored at the duodenal bulb and ending in the jejunum Endoscopic placement & removal	In U.S. clinical trial Not currently FDA approved
Duodenal mucosal resurfacing	Fractyl Lexington, MA	Endoscopic thermal ablation of the duodenal mucosa using a balloon filled with heated water	In U.S. clinical trial Not currently FDA approved
Gastroduodenal-jejunal bypass	ValenTx Inc. Hopkins, MN	120cm liner anchored at the GEJ and ending at the jejunum	Not currently FDA approved
Incisionless magnetic anastomosis system	GI Windows West Bridgewater, MA	Self-assembling magnets that form a compression anastomosis between the jejunum and ileum	Not currently FDA approved

Data:

GI Dyanmics had 22 patients with barrier placement of 12 months duration with mean weight loss of 49.5 lbs (20%). Additionally, 8 patients with diabetes had improved HgbA1c and decreased diabetes medication requirements. Improvements were also seen in cholesterol levels and blood pressure control.
Of the original 30 patients, 4 could not have the device placed for technical reasons and another 4 had complications including continuous pain, migration, and obstruction.

IGBs are free-floating and although improved materials are available i.e. non-toxic silicone elastomer resistant to stomach acid – spontaneous and unpredictable deflation may occur leading to obstruction symptoms which may require emergent surgery.
This safety issue is hampering FDA approval.
Barriers require being secured in place to the intestine (gastrointestinal tract) using barbs, hooks, or sutures. Such attachments have not been shown to be durable; therefore migration and obstruction still occur.
Four out of 30 patients (13%) with migration/obstruction is unacceptable and also hindering FDA approval.