24 December, 2023

What Companies Make Gastric Weight Loss Balloons?

Gastric balloons are becoming more popular for weight loss because the procedure for placement takes only minutes, there are no incisions, no hospital stay, and no permanent changes are made to the patient’s stomach or digestive system.

Gastric weight-loss balloons are placed temporarily in the stomach and then removed. During the balloon’s placement, the patient follows a supervised weight loss program and becomes aware of the brain-to-stomach communication system so they can adjust their eating habits.

The patient works with a team of professionals to address any behaviors that contribute to weight gain, and they learn real-life strategies that will convert these behaviors into healthy lifestyle habits. Patients continue practicing these new lifestyle habits after the balloon is removed so they can reach their target weight loss goal and maintain it long-term.

Currently, there are only three weight loss balloons used in the United States that have FDA approval. Today, we are going to discuss a bit about these three weight loss balloons and the companies behind them.

What Companies Manufacture The Gastric Balloons Used In The U.S.?

The weight loss balloons that are FDA-approved and used for weight loss in the U.S. are as follows:

  1. The Orbera Balloon is manufactured and distributed by Apollo Endosurgery, Inc., which is based in Austin, Texas;
  2. The Obalon balloon was manufactured and distributed by Obalon Therapeutics Inc., based in Carlsbad, California;
  3. The Spatz3 Balloon is manufactured and distributed by Spatz Medical, Inc., based in Ft. Lauderdale, Florida.

How Do The Three U.S. FDA-approved Weight Loss Balloons Compare?

Although the weight loss balloons work in a very similar manner, there are some unique differences between the three available to weight loss patients in the U.S. today.

The Orbera Balloon

The Orbera balloon uses a single balloon that is filled with a liquid saline solution. It is spherical in design and totally smooth. (It is the only balloon on the market that has all of the features outlined in the landmark Tarpon Springs Conference, where a group of international experts defined the parameters of the “ideal” weight loss balloon.)

The balloon is placed and removed during an endoscopic procedure that takes about 20 minutes. Patients utilizing the Orbera weight loss balloon lost an average of 15% of their total body weight in six months, and many motivated patients lost much more.

Some side effects of the Orbera weight loss balloon are nausea and vomiting during the first week as the stomach becomes accustomed to the balloon. Almost 80% of patients in research studies experienced this type of discomfort for at least a few days while using a liquid-filled balloon; however, it offers the most favorable weight loss results.

More About The Manufacturer Of The Orbera Balloon

Apollo Endosurgery Inc., based in Texas, develops and distributes medical devices used during less invasive gastrointestinal procedures including those performed to treat obesity.

The company not only manufactures the Orbera balloon but also the endoscopic tool Overstitch, which is used for strategically placing full-thickness sutures during the non-surgical endoscopic sleeve gastroplasty procedure. Apollo Endosurgery continues to lead the industry in the future of weight loss through its contributions used for procedures that promote weight loss without surgery.

The Orbera balloon has over 30 years of history and statistical data in the marketplace, as it was used in multiple countries for over two decades before being approved for use in the U.S. in 2015. Every other weight loss balloon manufacturer has taken the research and development information yielded from the Orbera balloon and expanded on it for their own design.

The Obalon Balloon

The Obalon balloon is actually a series of three balloons that are placed into the patient’s stomach during three separate office visits spaced one month apart.

During each visit, the patient swallows a capsule-like pill that contains the balloon, then the patient must undergo an x-ray using contrast dye to make sure the balloon is in the right location before it is filled. Next, the balloon is filled with nitrogen gas. After six months, all three gas-filled balloons are removed using the same basic endoscopic procedure that is utilized to remove all gastric balloons.

The side effects of the Obalon balloon were milder than with the liquid-filled balloons, with only 55% of patients experiencing nausea; however, the weight loss results only averaged around 7% of the patient’s total body weight. This is less than half the amount of weight lost by patients who used liquid-filled balloons.

More About The Manufacturer Of The Obalon Balloon System

Obalon Therapeutics first offered the balloon system through two company-owned retail locations, one in San Diego, CA, and a second in Orange County, CA, that treated patients directly. Unfortunately, the company suffered financially as a result of the COVID-19 crisis. The company merged with Reshape Lifesciences and is now based in San Clemente, California. The company website states that the company is currently undergoing an internal redesign and that, therefore, the Obalon balloon system is not currently available commercially.

The Spatz3 Balloon

The Spatz3 balloon is placed in the same manner as the Orbera balloon and is also filled with a solution of saline. The difference between the two is that the volume of liquid in the Spatz3 can be adjusted at any time during the eight months it is inside the patient’s stomach. The idea is that an increase in volume can help patients whose weight loss stalls out during their program, and a decrease in volume can help alleviate discomfort for patients who are experiencing chronic nausea and side effects.

A higher percentage (90%) of patients experienced the side effects of nausea and vomiting during the Spatz3 balloon adjustment time than with Orbera, and some patients experienced ulcers (4%) with a total complication rate of 16.4%.

More About The Manufacturer Of The Spatz3 Balloon System

The Spatz3 balloon was designed by Dr. Jeff Brooks and was based on an attempt to improve on the Orbera balloon’s design by making it adjustable during the duration of the patient’s weight loss program and allowing for the balloon to remain in the patient’s stomach for a longer period of time.

A study that compared several weight loss balloons reported that the adjustability factor did not make any notable difference in patient weight loss during clinical trials. Also noteworthy is that the Spatz3 has a long tail-like filling valve that hangs loose, similar to a “tail” that floats loose, which is not in keeping with the Tarpon Springs Conference directives, which indicate the ideal weight loss balloon be completely smooth.

The Spatz3 has only recently been approved by the FDA for use in the United States so more research is needed to determine long-term efficacy, side effects, and complication rates.

Which Weight Loss Balloon Is The Most Sought After?

The weight loss balloon that is most widely used for its efficacy and safety profile is the Orbera balloon. It has the longest history, has had the most clinical trials and research, and has collected the most data with which to conduct studies and comparisons.

At Simmons MD Advanced Weight Loss Solutions, we offer weight loss procedures that utilize the expertise of the industry leader Apollo Endosurgery, such as the Orbera balloon and the newer FDA-approved ESG (endoscopic sleeve gastroplasty). ESG uses the Overstitch endoscopic suturing device to place sutures into the stomach to hold it in a smaller shape to assist patients with portion control and satiety. The Overstitch device is also used during a bariatric revision procedure to repair deviations that can occur after a previous bariatric surgery, resulting in weight gain.

Non-surgical weight loss options offer patients the ability to lose weight without having to be exposed to the risks and complications of surgery or extended recovery times. Most patients qualify for these non-surgical procedures, which are great for those with lower or higher BMI numbers who would not qualify for traditional bariatric surgery.

If you are suffering from obesity or weight-related conditions such as type 2 diabetes or high blood pressure, we can help you lose weight and keep it off. The experts at Simmons MD Advanced Weight Loss Solutions can create a customized program that is designed with your circumstances in mind. We can help identify any underlying conditions that may have held you back during precious weight loss attempts and make your efforts yield results.

Contact us today to set up an appointment to find out more about how the Orbera weight loss balloon or other non-surgical options can help you experience sustainable weight loss.

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