A new adjustable intragastric balloon appears to help obese patients lose significant amounts of weight and could be more tolerable than traditional intragastric balloons which must be removed after six months, according to a study presented this week at the annual Digestive Disease Week meeting in New Orleans. Six month data from a pilot study of Spatz-FGIA (Jericho, New York) Adjustable Balloon System were presented in a poster at the meeting. "Our excellent results are due, in part, to our ability to adjust the gastric balloon to fit each patient's requirements," said lead investigator Evzen Machytka, MD, from the University Hospital Ostrava (Ostrava, Czech Republic). "We believe that the results of this study underscore the potential of the Spatz gastric balloon as a safer, longer-term nonsurgical endoscopic approach to weight management than traditional intragastric balloons used today."
The study included 18 patients (15 female, 3 male), average 38 years old, with a mean body mass index (BMI) rating of 39.4 and a mean weight of 252.8 pounds who were implanted with the Spatz™ Adjustable Balloon System. After implantation, the gastric balloons were filled with 400 ccs of saline, on average, to occupy about one-third of these patients' stomachs. Patients were discharged on three days of liquid diet and were then asked to maintain a 1200 calorie a day diet and take proton pump inhibitors.
After six months from the time of balloon implantation, four of the five balloons were in place and these four patients were able to lose more than half of their excess weight (50.8% EWL with a mean weight loss of 51.8 pounds), the company reported. A specially-designed valve on the Spatz™ Intra Gastric Balloon system allows the balloon volume to be adjusted in the patient's stomach via a routine endoscopy procedure, the company said. These volume adjustments enabled renewed balloon effect after the first two to three months in this study. Two patients who did not tolerate the gastric balloon in the first two weeks, had their balloon volumes decreased, allowing them to continue with the treatment.
Patients complained of varying degrees of nausea, vomiting or abdominal pain for up to five days, however none of these symptoms required the balloon to be removed, the company said. One patient with moderately severe gastritis (inflammation of the stomach lining) at implantation requested device removal at day 40 due to an upset stomach, the company acknowledged. Endoscopy revealed non-healing H. Pylori astritis and the device was removed uneventfully. Follow up endoscopy two months later revealed complete healing of the gastritis and eradication of the H. Pylori, according to Spatz. Investigators plan to extend the study for another six months to determine if an adjustable intragastric balloon can be a solution for chronic endoscopic weight loss therapy. |
|
NEW ORLEANS, Louisiana - A new adjustable intragastric balloon appears to help patients with obesity lose significant amounts of weight and could be more tolerable than traditional intragastric balloons, which must be removed after six months. Six-month data from a pilot study of Spatz-FGIA Inc.'s Adjustable Balloon System were presented in a poster at Digestive Disease Week (DDW) 2010 in New Orleans, Louisiana. The study included 18 patients (15 female, 3 male), average 38-years old, with a mean body mass index (BMI) rating of 39.4kg/m2 and a mean weight of 114.9kg (252.8lbs), who were implanted with the Spatz™ Adjustable Gastric Balloon System. After six months from the time of balloon implantation, four of the five balloons were in place and these four patients were able to lose more than half of their excess weight (50.8% EWL with a mean weight loss of 23.5kg (51.8 lbs).
A specially-designed valve on the Spatz™ Balloon System allows the balloon volume to be adjusted in the patient's stomach via a routine endoscopy procedure. These volume adjustments enabled renewed stomach balloon effect after the first two to three months in this study.
Investigators plan to extend the study for another six months to determine if an adjustable intragastric balloon can be a solution for chronic endoscopic weight loss therapy. For more information, visit www.ddw.org. |
Copyright © 2011 Spatz FGIA Inc. All Rights Reserved. | Intra Gastric Balloon Weight Loss Therapy