Adjustability in Gastric Balloons increases success rates to 84%

This 2024, the global leader of gastrointestinal weight loss solutions, Spatz Medical, has begun the commercialization of the Spatz3 Adjustable Gastric Balloon in the United States. The company has already offered its services to more than 150,000 patients across sixty markets worldwide. Now, they are going to launch their new and unique technology in the market of the United States.

The Spatz3 Adjustable Gastric Balloon is the first and only adjustable gastric balloon on the market. It has garnered overall recognition for its impressive results as a weight loss option. At the FDA Pivotal trials, it has proved to have an 84% success rate applied to real-world cases. The CEO of Spatz Medical, Dr. Jeffrey Brooks, developed the product with a new adjustability feature. This unique feature allows physicians to adjust the size of the balloon during treatment and therefore customize its volume for each patient. This can help prevent and adapt to challenges that are often present during traditional gastric balloon procedures.

After testing its efficacy and safety, the FDA Pivotal Study was published in The Lancet. Some of the remarkable results demonstrated that the Spatz3 patients attained a reduction of 15% in initial weight, while other control groups achieved a 3% weight loss, accomplishing a weight loss five times as big. Furthermore, 74.3% of the patients were able to maintain clinically significant weight loss six months after the removal of the balloon, proving a successful weight maintenance.

One of its unique features is the extended treatment period. Standard non-adjustable gastric balloon procedures last six months, but Spatz3 can reach up to eight months. This extended period allows patients to integrate healthy eating habits into their daily lives. This new lifestyle implementation is part of a behavior modification program and supervised long-term diet to make sure that the patient practices healthy habits, and it increases the possibility of long-term weight loss maintenance after the balloon is removed.

The most important feature of Spatz3 is its unique adjustable component, because it can adjust its size to become smaller or larger, and it can relieve intolerance in 82% of cases and lead to 15.2% excess weight loss. These adjustments take as long as the initial procedure, approximately 15 minutes.

It is common that patients hit a weight loss plateau between the second and fourth month, that is why the first increase in size usually happens in the 4-month mark.

Often, the size decrease is given due to the patient’s intolerance to the gastric balloon. This happens to 10% of the patients, and the balloon can be decreased in size to alleviate the intolerance and avoid having to remove the gastric balloon altogether.

This flexibility enables physicians to tailor the treatment to the patient’s evolving needs and makes Spatz3 have the highest likelihood of successful weight loss. The balloon can hold between 300 and 850 ml and can have 100-150 ml removed or 200-300ml added as needed. 

Dr. Jeffrey Brooks stated that the FDA Post Approval Study and the results of the clinical trial prove a critical moment for Spatz Medical. In gastric balloon history, this is the first time when an adjustable gastric balloon allows the patients to play a more active role in their weight loss journey, as the adjustments are tailored to the needs and preferences of each patient. Because of its already global presence as well as the impressive number of 150,000 patients who have benefitted from Spatz3, Dr Jeffrey Books is excited to offer this effective solution to patients around the United States.

Professor Barham Abu Dayyeh MD, an investigator of Bariatric Endoscopic procedures in the US as well as the principal investigator of the Spatz3 FDA Pivotal Trial and Post Approval Study, further praised the new technology. He stated that the Spatz3 provides a new element in endoscopic bariatrics with its adjustability feature. Being able to change the volume of the balloon depending on the patient’s needs during the treatment generated a 15% total body weight loss, as well as an 84% success rate in FDA clinical trials.

Spatz Medical has a continued commitment to innovation to advance in the field of bariatric endoscopy. The adjustability feature of the Spatz3 represents a fundamental change for intragastric balloons. This provides new solutions for patients, such as preventing early intolerance by filling the balloon gradually rather than having it completely at its maximum size from the beginning, as well as a rejuvenation option in case the patient experiences a weight loss plateau.

The Spatz3 is approved for use in adults who deal with obesity with a  BMI of 30–40. It’s the perfect solution for patients who have obesity-related comorbid conditions and have struggled to achieve or maintain weight loss through traditional methods, or who have failed with standard non-adjustable balloons.

The arrival of the Spatz3 adjustable gastric balloon to the US market represents a life-changing step in weight loss solutions. With its unprecedented success rate and unique adjustability feature, the Spatz3 offers a customizable option to the patient’s requirements. As Spatz Medical continues to introduce advances in bariatric endoscopy, the Spatz3 is on its way to becoming the foundation in weight loss therapy, encouraging patients to accomplish and maintain significant weight loss.