The FIRST and ONLY FDA-approved 6-month, swallowable, gas-filled weight loss balloon system.
Incidence of serious events in the SMART trial (n=1/336)
of extensive research and testing, resulting in next-generation of weight loss balloons. FDA approval was based on the most rigorous study design: double-blinded, randomized and sham-controlled.
patients have received the Obalon Balloon System worldwide.
Obalon bridges the gap between diet and exercise and surgery for patients with a body mass index (BMI) of 30 to 40 kg/m2
Swallowable: Non-surgical placement – The patient swallows a capsule with no anesthesia. Administration is discreet. It takes about 10 minutes with no down time for the patient.
Progressive Doses of Volume: Progressive weight loss – Adding balloons over time gradually increases the volume of occupied stomach space. Balloons are designed to help patients overcome weight loss plateaus and minimize side effects.
Floats: Feel fuller faster – Obalon balloons are gas-filled and float to the top of the stomach. Designed to reduce adverse symptoms and improve tolerability.
Pivotal Trial Highlights of 160 patients1
Patients in the SMART trial lost twice as much weight with Obalon combined with diet and exercise vs. diet and exercise alone.
Average weight lost kept off six months after balloons were removed. *
Commercial Registry Data of 787 patients2
Total Body Loss
Commercial weight loss data based on Obalon's physician reported commercial registry.
1. Sullivan et al., Randomized Sham-Controlled Trial of Six-Month Swallowable Gas-Filled Intragastric Balloon System for Weight Loss. Surgery for Obesity and Related Diseases 14 (2018) 1876-1889 2. Moore et al. (In Press), Clinical Safety and Effectiveness of a Swallowable Gas-filled Intragastric Balloon System or Weight Loss: Consecutively Treated Patients in the Initial Year of US Commercialization. Surgery for Obesity and Related Diseases.
*When combined with an appropriate diet and exercise program
WHAT MAKES OBALON STAND OUT?
Swallowable Capsule
- ~10 min procedure per balloon
- Easily add balloon volume over time
Gas-filled Balloon
- Lightweight & buoyant
- Very durable
- Designed for patient comfort
The Obalon Navigation System
The Obalon Navigation Console features Dynamic Visualization to monitor the balloon capsule throughout the placement procedure.
Easy to Use
- Designed for intuitive balloon placement
- Dynamic tracking of the balloon’s path and location prior to inflation
- System notifications displayed on a digital touchscreen throughout the administration process
Clinically proven safety
- 100% accurate balloon location determination in the COBALT clinical study
Portable and convenient
- Has a small footprint and is mobile
- The system can be operated in a variety of practice settings
Easy to incorporate into your practice
- The Navigation System uses low energy EMF and does not require state licensure or radiation exposure monitor
Easy, one-touch balloon administration
Initiates balloon inflation process with a single start button
Controlled inflation
Regulated pressurization designed to ensure safe and reliable inflation every time
Digital display
Touchscreen displays system pressure and balloon information throughout the inflation process
Lightweight balloons
Each balloon only weighs approximately 3 grams and has a volume of 250cc
Why Three Balloons
- 4.4x the weight loss vs. two balloons
- Facilitates progressive weight loss
- Designed to increase patient comfort and tolerability
What Makes Obalon Different
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"I’m very excited to have Obalon in my practice, patients are already calling and asking about it."
Aurora Pryor, MD
Professor of Surgery, Vice Chair for Clinical Affairs
Stony Brook University, School of Medicine. -
"I can do more balloons per day, Obalon is a better use of my time and, in the end, generates more revenue for my practice."
Helmuth Billy, MD
Medical Director
Ventura Advanced Surgical Associates, Ventura CA -
"One of the most remarkable findings in the clinical trial was that patients were able to keep their weight loss."
Aurora Pryor, MD
Professor of Surgery, Vice Chair for Clinical Affairs
Stony Brook University, School of Medicine -
"The accessibility and privacy of just swallowing it and just going home, having it in place…that’s everything."
Robin Blackstone, MD
Medical Director
Center for Diabetes and Obesity, University of Arizona -
"The SMART trial which looked at the effects of the Obalon system was a very rigorous trial, it's considered one of the Gold Standards of studies when we look at devices."
Shelby Sullivan, MD
Associate Professor of Gastroenterology
University of Colorado, School of Medicine
Obalon Is Committed
To Your Practice Success
We partner with you to provide marketing support and patient flow.
The Obalon Balloon System is a swallowable intragastric balloon system indicated for temporary use to facilitate weight loss in adults with obesity (BMI of 30 – 40 kg/m2) who have failed to lose weight through diet and exercise. The System is intended to be used as an adjunct to a moderate intensity diet and behavior modification program. All balloons must be removed six months after the first balloon is placed.