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271 lb : 178 lb

Obesity treatment that’s easier for your patients to


Introducing the TOGA™ System for transoral gastroplasty
• Non-invasive — Incisionless Procedure
• Proven Mechanism — Restrictive Pouch
• Established Technology — Titanium Staples

TOGA™ PROCEDURE

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Endoscopy is performed. The TOGA A retraction wire is deployed to
Sleeve Stapler is inserted over a spread the stomach tissue.
guidewire. The endoscope is
reintroduced for real-time visualization.

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This creates a sleeve along the The process is repeated to create
lesser curve. a sleeve of desired length.
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endoscopic view endoscopic view
Vacuum is applied and tissue is The Sleeve Stapler is closed and
acquired from the anterior and fired, delivering 33 titanium staples
posterior stomach walls. in a 4.5cm staple line.

CAUTION: Investigational device. Limited by U.S. law to investigational


use. The TOGA System is not approved by any regulatory agency.

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The TOGA Restrictor is inserted to The resulting pouch is intended to
create stapled pleats at the outflow provide a feeling of fullness after a
tract of the new sleeve. small meal.
SAFETY AND FEASIBILITY OF TRANSORAL GASTRIC STAPLING FOR OBESITY: FIRST HUMAN MULTICENTER STUDY
J. Devière(1), G. Ojeda Valdes(2), L. Cuevas Herrera(2), J. Closset(1), O. Le Moine(1), P. Eisendrath(1),
C. Moreno(1), S. Dugardeyn(1), M. Barea(1), R. de la Torre(3), S. Scott(3)

(1)Gastroenterology, ULB - Hôpital Erasme, Brussels, Belgium, (2)Surgery, Hospital Regional 1st de Octubre,
Mexico City, Mexico, (3)Surgery, University of Missouri, Columbia, Missouri

ABSTRACT
BACKGROUND: We report safety and feasibility results from the first human trial of a new endoluminal stapling device (TOGATM System) for obesity.

METHODS: Ethics committee approval was obtained, and patients underwent informed consent. Patients were recruited based on established criteria
for bariatric surgery. With patients under general anesthesia, the TOGA System was used to create a stapled restrictive pouch along the lesser curve
of the stomach. Patients were kept overnight for observation. Follow-up was completed at 1 week and 1, 3, 4, 5 and 6 months. RESULTS: Twenty one
patients were enrolled and treated (17 female, age 43.7 (22-57), BMI 43.3 (35-53)). There were no serious adverse events. The most common procedure
or device related AEs were vomiting, pain, nausea and dysphagia. At 6 month follow-up, full or partial stapled sleeves were visible in all patients.
Average weight loss was 17.6 pounds (8.0 kg) at 1 month, 24.5 pounds (11.1 kg) at 3 months, and 26.4 pounds (12.0 kg) at 6 months post-treatment.
Excess weight loss was 15.0%, 20.9% and 23.7% at 1, 3 and 6 months, respectively.

CONCLUSIONS: There is great interest in new less invasive, transoral procedures for morbid obesity. This early experience indicates that the
TOGAprocedure may be a safe and feasible approach. Further experience with the device and technique should improve anatomic and functional
outcomes in the future. Additional studies are underway.

(Abstract presented at IFSO 2007)

Satiety, Inc. 2470 Embarcadero Way, Palo Alto, CA 94303 Phone: 650-320-2100 Fax: 650-320-2150
www.satietyinc.com