Spatz Gastric Balloon

The Spatz Gastric Balloon is a third-generation medical device that stands out for its adjustable volume feature. It has been developed in accordance with the requirements of the Tarpon Springs Conference. The greatest advantage of this device is that the balloon’s volume can be increased or decreased during the treatment. Additionally, it can stay in the stomach for a full 360 days, providing patients with continuous weight loss opportunities. However, according to the manufacturers, the part of the balloon known as the “tail” may cause some difficulties. It has received the CE mark from the European Union and has also recently been approved by the FDA.

What is the Spatz Gastric Balloon?

The Spatz Gastric Balloon is an innovative medical device placed in the stomach to support weight loss. Its spherical structure and silicone material increase its suitability for long-term use. The distinguishing feature of this balloon is that its volume can be adjusted according to the patient’s needs. The intra-gastric volume can be increased or decreased depending on patient tolerance and weight loss goals. This adjustment is made through a valve and a filling catheter.

The main components of the balloon are:

• Balloon: A silicone structure inflated with saline that can vary between 400-700 mL.
• Anchor: A silicone coating with an internal network structure that ensures the balloon stays in place and prevents migration.
• Filling Tube: A retractable silicone structure connected to the balloon to adjust the intra-gastric volume.

The placement of the balloon is done through an endoscopic procedure, and the entire process is visually monitored. This is critical to prevent the risk of inflation in the esophagus. The procedure is performed once the balloon is fully positioned in the gastric cavity.

The balloon volume can be increased or decreased from the initially determined amount. These adjustments help the patient adapt to the weight loss process and are made considering the following situations:

• When signs of intolerance, such as excessive and constant vomiting, are shown in the first days.
• When the patient stops losing weight or the weight loss slows down.
• When there is a decrease in the feeling of fullness.

The balloon should be removed at the end of the 12-month usage period. This procedure is performed similarly using an endoscope and requires anesthesia. The defined irregular morphology of the Spatz Gastric Balloon can make the extraction process difficult. The balloon is a device that requires special techniques both during placement and removal, so it must be managed carefully.

What Impact Does the Adjustability of the Spatz Gastric Balloon Have?

The adjustable features of the Spatz Gastric Balloon offer a new dimension in weight control. In line with the requirements highlighted at the Tarpon Springs Consensus meeting, these balloon systems allow for volume adjustments according to patient needs. This provides the opportunity for continued adjustments even after implantation.

Initial Studies: The first comparative studies were conducted between 2010 and 2014.

• Patient Groups: In the first study, 20 elderly patients were treated with BioEnterics IGB and 10 patients with the Spatz Adjustable Balloon System.
• Results: Comparisons were made between both groups in terms of weight loss, complications, and weight maintenance.

In these studies, the adjustable volume of the Spatz Gastric Balloon added flexibility to the treatment process. Particularly when volume adjustments were made, it was possible for patients to better adapt to tolerance levels. However, no significant difference was observed between the groups with and without volume adjustments.

Large-Scale Research:

• US Study: Researchers examined the efficacy and safety of Spatz3 in 187 patients across 8 different centers.
• Efficacy: The total weight loss percentage in the treatment group was 14.9%, while it was 3.6% in the control group.
• Safety: Serious adverse events were reported in 5.3% of cases during the treatment.

In another study conducted by researchers, patients with volume adjustments of the Spatz3 balloon lost an average of 4.35 kg more compared to the group without volume adjustments.

Cross-Sectional Study:

• Participants: In a study conducted by researchers, 470 overweight or obese patients were examined.
• Results: Similar weight loss rates were obtained in both types of balloons.

The results of these studies indicate that the adjustable volume of the Spatz Gastric Balloon does not provide a significant weight loss advantage. However, it is noted that it facilitates patients’ adaptation to the treatment and provides better patient satisfaction.

How is the Balloon Different from Others and Who is It Ideal For?

The Spatz3 gastric balloon emerges as a pioneering innovation in the medical field. This device is a saline-filled balloon that occupies about one-third of the stomach. By limiting the stomach’s capacity, it helps you eat less. One of its standout features is that its volume can be adjusted during use. After initial placement and during the treatment, the volume can be increased or decreased as needed. This maximizes the user’s comfort while providing effective weight control.

Additionally, the duration the Spatz3 can stay in the stomach is significantly longer compared to other balloons. While other products in the US typically last a maximum of 8 months, the Spatz3 can be used safely for 12 months, which is twice as long. This long-term use offers an excellent opportunity to adopt permanent healthy eating habits.

Ideal candidates:

• Individuals aiming to lose at least 22 pounds (approximately 10 kg).
• Individuals with a BMI (Body Mass Index) value of 27 or 30 and above.
• Individuals not suitable for weight loss surgery or those who do not prefer such operations.
• Individuals who need to lose weight before surgery to reduce surgery-related risks.

These features make the Spatz3 a unique support tool in the weight loss process, offering users a long-term success chance.

How Does the Frequency and Process of Adjustments Work?

The Spatz Gastric Balloon stands out with its feature of being able to adjust the volume according to the user’s needs. This feature allows the weight loss process to be optimized according to individual needs. The balloon volume is adjusted considering the following situations:

• When weight loss stops or slows down,
• When the effect of the balloon is felt to decrease, usually two to four months later.

Adjustments made in these situations are planned to enhance the user’s comfort and the effectiveness of the balloon. Each adjustment procedure is performed quickly and safely with a 15-minute endoscopy procedure under conscious sedation. By increasing or decreasing the balloon volume, the weight loss process becomes more comfortable and effective. Adjustments play a critical role in improving the user’s experience and results.

How Does the Recovery Process Proceed with the Spatz Gastric Balloon?

After the placement of the Spatz Gastric Balloon, the patient begins the recovery process. The first few days are generally the most challenging. Most patients may experience symptoms such as nausea and vomiting during this period. These side effects gradually diminish as the body adapts to the new situation. During this initial phase of the recovery process, it is important for patients to rest and pay attention to their body’s signals. Below are the main points of the recovery process:

The first three or four days after the procedure:

• Nausea
• Vomiting
• Abdominal discomfort

During this period, it is important to rest at home and drink plenty of fluids. Additionally, taking four to five days off work provides the necessary time for recovery. If childcare is needed, arrangements should be made in advance for this period. Patients are free to progress at their own pace during the recovery process and should not rush to return to their normal routines. Listening to their bodies is the most important part of this process.

What Lifestyle and Dietary Changes Are Required?

With the Spatz Gastric Balloon, certain adaptations are required in your life. In particular, significant changes are expected in your eating habits. Initially, a liquid diet is followed, gradually transitioning to solid foods. The consumption of fibrous foods is restricted during this process. As your tolerance to fiber increases over time, vegetables and fruits can be gradually added to your diet.

• In the first weeks, a liquid diet is prioritized.
• The consumption of fibrous foods is restricted.
• Vegetables and fruits are gradually added to your diet.

With the balloon in place, your decreased appetite helps you eat less. However,

overeating can strain your gastric balloon and cause various digestive issues. Therefore, it is important to eat in moderation and have frequent small meals. Creating a nutrition plan with a dietitian helps you determine the most suitable diet for you. It is beneficial to consult your nutritionist before adding any new food items to your diet.

Regarding alcohol consumption, moderation is essential. Drinking a glass of wine a few times a week generally does not cause problems, but it should be noted that alcohol can increase the risk of stomach ulcers.

In the first weeks with the balloon, it may be necessary to slow down physical activities. As your body adjusts to the balloon, you can return to your normal activities. Exercising is beneficial for both your physical and mental health.

Regular monitoring and follow-up of your gastric balloon are also important. Regular check-ups with your doctor are required throughout the first year. These check-ups evaluate your health status and support your weight loss process. Additionally, regular consultations with your dietitian enhance the effectiveness of your nutrition plan and help you achieve your weight loss goals.

Whether or not the balloon is felt in the stomach varies from person to person. Some patients may feel slight discomfort in the first days. However, these feelings generally diminish over time, and the presence of the balloon is often forgotten.

What Are the Side Effects and Management Strategies of the Spatz Gastric Balloon?

The Spatz Gastric Balloon is a significant aid in the weight loss process. Within the first few days, users typically experience nausea, vomiting, and various stomach pains. Doctors will recommend various medications to manage these side effects. Such side effects usually begin to decrease within the first week. Users may experience side effects related to the amount and type of food consumed once they transition to semi-solid foods and then to solid foods after two weeks. An unbalanced diet can lead to issues such as bloating, constant burping, and stomach pain.

Points to consider for managing side effects:

• Antiemetic medications can be used for nausea and vomiting.
• Antacids and other stomach-protective medications can be helpful for stomach pain.
• Ensuring the diet is balanced and suitable for the patient’s needs.

The expected weight loss with the Spatz Gastric Balloon varies based on personal commitment and the applied diet plan. When supported by healthy eating habits and regular physical activity, users can typically lose between 14 kg and 25 kg. However, there will also be those who lose only a small amount of weight. Success depends on the commitment to lifestyle changes. Maintaining continuous communication with the doctor throughout the weight loss process is crucial to prevent potential health issues.

In the event of spontaneous deflation of the balloon, the balloon containing blue liquid can turn the urine green. In such a case, users should immediately contact their doctors. An appointment will be arranged for the removal of the balloon. The balloon can remain in the stomach for up to 12 months, and medications are given for acid control in the stomach during this period. These medications help reduce stomach irritation and keep the balloon in optimal condition.