Spatz FGIA Announces First Implants of Spatz Adjustable Intragastric Balloon System

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Spatz FGIA, Inc., a privately held medical device company, today announced the first implants of its Spatz Adjustable Balloon System. The Spatz Adjustable Balloon System is a non-surgical weight loss therapy for the overweight and obese. The system's innovative features offer greater weight-loss success, increased patient safety, and ease of use for the physician.

Spatz FGIA, Inc., a privately held medical device company, today announced the first implants of its Spatz Adjustable Balloon System. The Spatz Adjustable Balloon System is a non-surgical weight loss therapy for the overweight and obese. The system's innovative features offer greater weight-loss success, increased patient safety, and ease of use for the physician.

The first Spatz Balloon implants were performed by Dr Evzen Machytka, MD, PhD, at the University Hospital in Ostrava, Czech Republic, on October 13 and 14, 2009. The five patients who underwent the balloon placement procedure were observed overnight in the hospital and discharged the following day. In the coming months, these patients will participate in follow-up consultations for post-placement monitoring and confirmation of successful weight loss.

Dr Machytka stated that obesity is considered the number one health issue facing the world population, and explained how intragastric balloon weight loss therapy contributed to solving this world-wide problem.

"Over 1 billion people are overweight, with 300 million obese. Obesity is associated with several chronic illnesses, including diabetes, atherosclerosis, heart disease, liver disease and some cancers. Intragastric balloons have been used in weight loss therapy for the last 15 years in approximately 100,000 patients. An average weight loss of 15 kg or more over six months has been achieved safely and successfully. Weight loss has been shown to significantly diminish and sometimes even reverse some of these associated diseases."

Dr Machytka briefly described intragastric balloon placement and explained how it promotes weight loss.

"Using a non-surgical endoscopic procedure, the deflated balloon is inserted into the patient's stomach through the mouth of a sedated patient. The balloon is then filled with saline, or in some cases air, to occupy about one third of the stomach. This provides a feeling of satiety, stimulating hormonal influences, and slowing stomach emptying, thereby diminishing appetite. After six months, the balloon is removed from the patient's stomach via a simple procedure. Support by a dietician or nutritionist before, during, and after balloon removal promotes proper eating habits, ensuring successful weight loss and maintenance of that loss."

The Spatz Adjustable Balloon System has an innovative valve, allowing the balloon volume to be adjusted in the patient's stomach via a routine endoscopy procedure.

Dr Machytka praised the balloon's ease of post-implant adjustment and its removal mechanism.

"Locating and operating the Spatz System's valve was straightforward. I plan to customize the balloon size at least once during the course of treatment for each patient, to achieve better weight loss results. After implantation, I adjusted some of the balloons - both increasing and decreasing volumes. The highly visible blue extraction clasp at the end of the catheter is a good innovation. I believe it will make balloon extraction with a polypectomy snare much easier, and will not require purchase of a special tool. "

Dr Machytka explained how another unique feature of the Spatz Adjustable Balloon System provides improved patient safety.

"Due to the acidity naturally present in the stomach, intragastric balloons can develop leaks, causing the balloon to deflate. If this happens, the balloon can migrate through the digestive system. This occurs infrequently, and in the majority of cases, the balloon will simply pass through the patient's system without incident. However, there have been cases where surgical intervention was necessary. The Spatz System has a patented uncrushable catheter 'tail' attached to the balloon, preventing it from leaving the stomach. Should the balloon deflate, it will remain harmlessly in the stomach until removed via a standard endoscopy procedure."

Spatz FGIA CEO and System designer Dr Jeffrey Brooks, a gastroenterologist with over 20 years clinical experience, explained how the uncrushable 'tail' feature will enable the Spatz Adjustable Balloon System to remain in the patient's stomach for a longer period, increasing weight loss potential.

"Currently, intragastric balloons must be removed after six months, due to the rising incidence of balloon deflation after six months, which in turn increases the risk of intestinal obstruction. Spatz FGIA will be presenting evidence to the European regulatory authorities to show how the Spatz Adjustable Balloon System's special uncrushable 'tail' eliminates this risk. Until the regulatory authorities approve leaving the balloon in place for longer periods, patients and physicians will be advised to ensure removal of the Spatz System after 6 months."

Dr. Brooks expressed excitement over the first implantations of the Spatz Adjustable Balloon System, and stated that the System would soon be available in Europe. He invited medical device distributors to contact him to discuss including the Spatz Adjustable Balloon System in their product line.

"I am delighted with the performance of our System. It will not only provide more effective weight loss, but increased patient safety and physician confidence."

** Spatz and Spatz Adjustable Balloon are trademarks of Spatz FGIA, Inc.

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Dr Jeffrey Brooks
Spatz-FGIA, inc
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