NEW ORLEANS, May 3 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. Six month data from a pilot study of Spatz-FGIA Inc.'s Adjustable Balloon System were presented in a poster today at Digestive Disease Week (DDW) 2010 in New Orleans (abstract M1507).
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"Our excellent results are due, in part, to our ability to adjust the balloon to fit each patient's requirements," stated lead investigator Dr. Evzen Machytka, University Hospital Ostrava, Czech Republic. "We believe that the results of this study underscore the potential of the Spatz balloon as a safer, longer-term non-surgical endoscopic approach to weight management than traditional intragastric balloons used today."
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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 an mean weight of 114.9 kg (252.8 lbs) who were implanted with the Spatz Adjustable Balloon System. After implantation, the 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 per day diet and take proton pump inhibitors (PPI).
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 23.5 kg (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 balloon effect after the first two to three months in this study. Two patients who did not tolerate the 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. One patient with moderately severe gastritis (inflammation of the stomach lining) at implantation requested device removal at day 40 due to an upset stomach (dyspepsia). Endoscopy revealed non-healing H.Pylori gastritis and the device was removed uneventfully. Follow up endoscopy two months later revealed complete healing of the gastritis and eradication of the H.Pylori.
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. "We are very encouraged that the hospital ethics committee has approved extension of the study for a total of 12 months using the original devices," added Dr. Machytka.
"To our knowledge, this will be the first 12 month implant study for intragastric balloons in the world," said Dr. Jeffrey Brooks, CEO of Spatz-FGIA Inc. "Given the results to date, we believe that the Spatz Adjustable Balloon system has the potential to overcome limitations with traditional gastric balloons."
About The Spatz(TM) Adjustable Balloon System
The Spatz(TM) Adjustable Balloon System consists of a balloon mounted on a curled non-crushable catheter, designed to avoid migration into the duodenum. The integrated balloon catheter system straightens over a guidewire, and is passed similar to an orogastric tube, under conscious sedation. Calibrations on the pusher identify the level of insertion. Inflation commences after endoscopic confirmation of balloon position below the GE-junction. An extractable inflation tube housed in the catheter is attached to an extension tube for inflation, snared endoscopically and pulled outside the mouth for volume adjustments while the IGB remains in the stomach. At the end of the implantation period, the IGB is extractable with a snare after deflation.
About DDW
DDW is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy and the Society for Surgery of the Alimentary Tract, DDW takes place May 1 - 5, 2010, at the Ernest N. Morial Convention Center, New Orleans, LA. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. For more information, visit www.ddw.org.
Media Contact: Kevin Cronin Lazar Partners Ltd. [email protected] 212-867-9212
SOURCE Spatz-FGIA Inc.
