FDA News

FDA approves swallowable intragastric balloon for obesity

The FDA has approved the Obalon Balloon System, a swallowable intragastric balloon for weight loss in adults with obesity for whom diet and exercise has failed, the manufacturer announced.

The Obalon Balloon System (Obalon Therapeutics) involves a balloon folded within a capsule that is swallowed and inflated with gas by a micro-catheter once it reaches the stomach, according to a press release. Two additional balloons are then swallowed and inflated over the next 3 months, and all three balloons are then endoscopically removed after the 6-month treatment period. The treatment is intended to be paired with a moderate intensity diet and behavior modification program.

“We participated in the Obalon clinical trial and are excited to now have the Obalon Balloon System readily available for our patients who have been frustrated by not being able to lose weight through diet and exercise alone,” Aurora Pryor, MD, director of the Bariatric and Metabolic Weight Loss Center at the Stony Brook University School of Medicine’s department of surgery, said in the press release. “The Obalon balloon is swallowable, can typically be placed in less than 10 minutes without the use of sedation or anesthesia and was well-tolerated by our patients in the clinical trial. Having now received FDA approval, we can begin treating more patients with the device.”

The clinical trial comprised 387 patients who were randomly assigned to receive the Obalon treatment or sham devices at 15 U.S. sites, along with minimal diet counseling. Around 65% of the treatment group had clinically meaningful weight loss of at least 5% total body weight compared with half of those in the sham group.

These data were initially presented earlier this year at Digestive Disease Week by Shelby Sullivan, MD, director of the Gastroenterology Bariatric and Metabolic Program at the University of Colorado School of Medicine, and will also be presented at Obesity Week this fall, according to the press release.

“The clinical trial design for the Obalon Balloon System was highly rigorous and the system demonstrated a favorable safety profile,” Sullivan said in the press release. “We were also pleased to see that patients tolerated the administrations of the Obalon balloon remarkably well with no recovery time needed. This is in contrast to other currently approved intragastric balloon devices, where most patients cannot immediately return to normal activities.”

This new treatment is expected to be available early next year to physicians who complete an Obalon training program, according to the press release. The company is currently working to ensure the product can be safely and effectively commercially implemented.

Disclosures: Pryor reports financial relationships with Ethicon, Medtronic, Gore, Apollo, and Intuitive. Sullivan reports financial relationships with Aspire Bariatrics, Baranova, GI Dynamics, Obalon, Takeda and USGI Medical.

The FDA has approved the Obalon Balloon System, a swallowable intragastric balloon for weight loss in adults with obesity for whom diet and exercise has failed, the manufacturer announced.

The Obalon Balloon System (Obalon Therapeutics) involves a balloon folded within a capsule that is swallowed and inflated with gas by a micro-catheter once it reaches the stomach, according to a press release. Two additional balloons are then swallowed and inflated over the next 3 months, and all three balloons are then endoscopically removed after the 6-month treatment period. The treatment is intended to be paired with a moderate intensity diet and behavior modification program.

“We participated in the Obalon clinical trial and are excited to now have the Obalon Balloon System readily available for our patients who have been frustrated by not being able to lose weight through diet and exercise alone,” Aurora Pryor, MD, director of the Bariatric and Metabolic Weight Loss Center at the Stony Brook University School of Medicine’s department of surgery, said in the press release. “The Obalon balloon is swallowable, can typically be placed in less than 10 minutes without the use of sedation or anesthesia and was well-tolerated by our patients in the clinical trial. Having now received FDA approval, we can begin treating more patients with the device.”

The clinical trial comprised 387 patients who were randomly assigned to receive the Obalon treatment or sham devices at 15 U.S. sites, along with minimal diet counseling. Around 65% of the treatment group had clinically meaningful weight loss of at least 5% total body weight compared with half of those in the sham group.

These data were initially presented earlier this year at Digestive Disease Week by Shelby Sullivan, MD, director of the Gastroenterology Bariatric and Metabolic Program at the University of Colorado School of Medicine, and will also be presented at Obesity Week this fall, according to the press release.

“The clinical trial design for the Obalon Balloon System was highly rigorous and the system demonstrated a favorable safety profile,” Sullivan said in the press release. “We were also pleased to see that patients tolerated the administrations of the Obalon balloon remarkably well with no recovery time needed. This is in contrast to other currently approved intragastric balloon devices, where most patients cannot immediately return to normal activities.”

This new treatment is expected to be available early next year to physicians who complete an Obalon training program, according to the press release. The company is currently working to ensure the product can be safely and effectively commercially implemented.

Disclosures: Pryor reports financial relationships with Ethicon, Medtronic, Gore, Apollo, and Intuitive. Sullivan reports financial relationships with Aspire Bariatrics, Baranova, GI Dynamics, Obalon, Takeda and USGI Medical.

    See more from Obesity Devices Resource Center