This is a brief overview of information related to FDA’s approval to market this product.  See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name:    Spatz3 Adjustable Balloon System
PMA Applicant:    Spatz FGIA Inc.
Address:        1801 S Perimeter Rd, Suite 130, Fort Lauderdale, FL 33309
Approval Date:    October 15, 2021
Approval Letter:    Approval Order

What is it?  

The Spatz3 Adjustable Balloon is a weight-loss device that is filled with saline and implanted in the stomach for up to eight months.

How does it work?  

A doctor uses an endoscope to insert the Spatz3 Adjustable Balloon into the stomach. The size of the Spatz3 Adjustable Balloon volume can be increased or decreased during the eight-month period to increase the space occupied by the balloon or reduce symptoms respectively. The Spatz3 Adjustable Balloon is removed endoscopically.

When is it used?  

The Spatz3 Adjustable Balloon System is intended for adults with a Body Mass Index (BMI) of 30.0 to 40.0 kg/m2 who have failed to achieve and maintain weight loss with a supervised weight control program. The Spatz3 Adjustable Balloon System is for use for up to eight months with a long-term supervised diet and behavior modification program designed to increase the possibility of long-term weight loss maintenance. 

What will it accomplish?  

In a clinical study, the Spatz3 Adjustable Balloon was implanted in 187 patients for up to eight months. Ninety-two percent (92%) of patients who received the device observed at least a 5% reduction in their total body weight and on average lost 15.0% of their body weight. In comparison, patients who did not receive the device lost 3.3% of their body weight. All patients in the clinical study (those who did receive the device and those who did not receive the device) received a moderate-intensity lifestyle counseling program.  

When should it not be used?  

The Spatz3 Adjustable Balloon System should not be used if any of the following apply: 

• Prior gastrointestinal surgery complications, such as recurrent abdominal pain, bowel obstruction, episodes of transient bowel obstruction, adhesive peritonitis (collection of fluids in the abdomen) or known abdominal adhesions (scar tissue), prior intestinal resection (surgery to remove all or part of the intestines), or prior multiple lower abdominal or pelvic surgeries.
• Prior open or laparoscopic bariatric surgery (for example, gastric bypass, gastric sleeve,  gastric band surgery).
• Prior surgery of any kind on the esophagus, stomach, duodenum (first part of the small intestine) or any type of hiatal hernia surgery.
• Any inflammatory disease of the gastrointestinal tract including esophagitis, Barrett’s esophagus, gastric ulceration (open sore in the stomach), duodenal ulceration (intestinal ulcer), or specific inflammation such as Crohn’s disease, or cancer or other diseases of the bowel system.
• Potential upper gastrointestinal bleeding conditions such as esophageal or gastric varices (enlarged veins), congenital or acquired intestinal telangiectasis (commonly known as spider veins), or other congenital anomalies (birth defects) of the gastrointestinal tract such as atresias (deformed tract) or stenoses (narrow tract).
• A gastric mass.
• A hiatal hernia greater than 2 cm or severe or intractable gastro-esophageal reflux symptoms.
• Acid reflux symptoms to any degree that require more than one medication for symptom control.
• A structural abnormality in the esophagus or pharynx such as a stricture (abnormal narrowing of the organ) or diverticulum (small, bulging pouches that form in the intestinal lining) that could block passage of the balloon alongside the endoscope.
• Achalasia or any other severe esophageal movement disorder that may pose a safety risk during the removal of the device.
• Severe coagulopathy (excessive bleeding or clotting).
• Insulin-dependent diabetes (either Type 1 or Type 2) or a significant likelihood of requiring insulin treatment in the following 12 months.
• Subjects with any serious health condition unrelated to their weight that would increase the risk of endoscopy.
• Chronic abdominal pain.
• Motility disorders (abnormal muscle and nerve contractions that cause spasms or lack of motion) of the gastrointestinal tract such as gross esophageal motility disorders, gastroparesis or intractable constipation.
• Hepatic insufficiency (liver failure) or cirrhosis (liver scarring).
• Serious or uncontrolled psychiatric illness or disorder that could compromise patient understanding of or compliance with follow-up visits and removal of the device after eight months.
• Alcoholism or drug addiction.
• Patients receiving daily prescribed treatment with more than 100 mg of aspirin, anti-inflammatory agents, anticoagulants (anti-clotting agents) or other gastric irritants.
• Patients who are unable or unwilling to take prescribed proton pump inhibitor medication (medications to reduce stomach acid) for the duration of the device implant.
• Patients who are known to have, or suspected to have, an allergic reaction to materials contained in the system.
• Patients who have BOTH ever developed a serotonin syndrome AND are currently taking any drug known to affect the levels of serotonin in the body (for example, selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs)) should not undergo placement of the device.
• Patients who are pregnant or chestfeeding by way of lactation.
• Patients with severe cardiopulmonary disease (range of diseases that affect the heart and lungs) or other serious organic disease that might include known history of coronary artery disease, myocardial infarction (heart attack) within the past six months, poorly controlled hypertension (high blood pressure), required use of nonsteroidal anti-inflammatory drugs (NSAIDs).
• Patients who are currently positive for Helicobacter Pylori (H. Pylori), a bacterial infection.
• Patients taking medications on specified hourly intervals that may be affected by changes to gastric emptying, such as anti-seizure or anti-arrhythmic heart medications.
• Patients who are taking corticosteroids (type of anti-inflammatory medication), immunosuppressants (medications to lower body’s ability to reject transplanted organs), or narcotics (type of medication with numbing or paralyzing properties used for pain relief).
• Symptomatic congestive heart failure (condition in which the heart is unable to pump enough blood to meet the body’s need), cardiac arrhythmia (irregular heartbeat) or unstable coronary artery disease.
• Pre-existing respiratory disease such as chronic obstructive pulmonary disease (COPD) or pneumonia (infection that inflames the lungs’ air sacs).
• Pre-existing cancer undergoing chemotherapy or radiation therapy.
• Diagnosis of autoimmune connective tissue disorder (for example, lupus, erythematous (abnormal redness of the skin), scleroderma) or immunocompromised (people with a weakened immune system).
• Life expectancy less than one year or severe renal (kidney), hepatic (liver), pulmonary (lung) or cardiac (heart) condition.
• Specifically diagnosed genetic or hormonal cause for obesity such as Prader Willi syndrome or untreated hypothyroidism.
• Eating disorders including night eating syndrome (NES), bulimia, binge eating disorder, or compulsive overeating.
• Untreated endocrine (hormone) disorders affecting weight.
• The presence of more than one intragastric balloon at the same time.

Additional information (including warnings, precautions, and adverse events):  

Summary of Safety and Effectiveness Data (SSED) and labeling are available at:

• Summary of Safety and Effectiveness Data
• Patient Labeling 
• Clinician Labeling 
• PMA Database Entry

Treatments for weight-loss and weight management range from healthy eating and exercise, to prescription medicine and surgery. FDA-regulated medical devices also help patients lose or manage their weight. Information about FDA-approved devices intended for weight-loss or weight-management: Weight-Loss and Weight-Management Devices | FDA

The FDA has alerted health care providers about potential risks with liquid-filled intragastric balloons. The Spatz3 Adjustable Balloon is a liquid-filled intragastric balloon. FDA’s alerts can be found here: https://www.fda.gov/medical-devices/letters-health-care-providers/fda-alerts-health-care-providers-about-potential-risks-liquid-filled-intragastric-balloons.