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Gastric Balloon Weight Loss Procedure |
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Safety |
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As with any medical procedure, there is an element of risk associated with intragastric balloons. Medical literature speaks of a low, but real risk of intragastric balloons deflating in the stomach, and beginning to move through the digestive tract. If the balloon passes naturally through the body, then all is well. There have, however, been cases where surgery has been required to remove the balloon. There have even been cases of death resulting from balloon deflation, which resulted in balloons being withdrawn from the US market.
The Spatz™ Adjustable Balloon System has a specially designed uncrushable catheter system which curls into shape when it reaches the stomach. Even if the balloon should lose all its fluid, this catheter will delay the balloon from travelling out of the duodenum – meaning that the balloon is safely within reach of the endoscope, for non-surgical removal, for a period of time. A patient, who finds that their weight loss has stopped, or has other reason to suspect that the balloon has deflated, can ask their physician to perform a simple x-ray or ultrasound examination to verify the situation. Any change in symptoms (new onset nausea, vomiting or pain) could signify a deflated balloon’s movement out of the stomach and requires immediate evaluation. Our anchor acts as an early warning system, and its warning should not be ignored. If necessary, a simple endoscopy can be performed to safely remove the balloon.
This special feature will provide an added advantage to assist weight loss. The chances of deflation of balloons increase over time, and because of the risk involved, regulatory authorities insist that balloons are removed after 6 months. Many patients would, of course, prefer a balloon that could stay in place more than six months, allowing weight loss to continue.
Spatz FGIA, Inc. is proud to announce that it has been officially approved to extend its implantation period from 6 months to 12 months. To our knowledge, this is the only balloon that has been approved for a 12 month implantation period. |
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| Easier to use |
The easier a product is for the physician to use, the safer it is for the patient.
We listened to physicians who told us that current intragastric balloons are often difficult to remove. Other balloons have their valves in the balloon wall – this makes it thicker and difficult to remove after 6 months. The Spatz gastric balloon is unique in that it has its valve outside of the balloon. This means it is relatively thinner and easy to remove.
The Spatz Adjustable Balloon System is specially designed so that when the time comes for removal, the physician uses a standard snare (which is used for many other purposes and is readily available in the clinic) in a procedure which is quick, straightforward and simple. |
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| Approved for 1 Year implantation |
Spatz is proud to announce its approval for 1 year intragastric balloon implantation.
A first for gastric balloons.
All other gastric balloons have 6 month implantation restrictions, due to the risk of balloon migration and bowel obstruction. The Spatz unique anchor has allowed the regulatory authorities to approve an extension of our implantation period from 6 months to 1 year.
Longer implantation time alone, is unlikely to produce greater weight loss, since non-adjustable balloons lose their effect on appetite within 3 to 4 months. However, the unique combination of longer implantation time and adjustability of the balloon volume can provide the means to achieve greater weight loss. |
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