In 2015, the FDA approved Apollo Endosurgery, Inc.’s Orbera Intragastric Balloon for weight loss. Now, the company shares in a press release, the device recently received Breakthrough Device Designation from the FDA for the treatment of patients with non cirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis (liver scarring). In particular, this designation is centered around patients with BMI 30-40, which normally indicates obesity.

Orbera Intragastric Balloon

On the Orbera website, it explains that:

The gastric balloon is inserted orally through your esophagus and placed directly into your stomach during a quick, non-surgical procedure. There is no need for any incisions, stitches or scars.

Once placed in the stomach, Orbera is filled with saline. Patients will have Orbera in their stomachs for about 6 months before removal. During this time, patients and their doctors work towards a healthier lifestyle program, which takes place over a 1-year period. The Orbera website states that the balloon can help patients lose up to 3x the weight compared to just diet and exercise.

In this case, Orbera would benefit patients with NASH who also have BMI 30-40. Some treatment guidelines suggest that patients who lose 7-10% of their total body weight have less of a chance of severe NASH-related symptoms, cirrhosis, or liver failure. Orbera should be used for patients who cannot or should not have surgery, but for whom exercise and diet alone are not reaching the intended results.

So far, Orbera has shown benefits in the Mayo Clinic IDE-approved study, which analyzed Orbera for patients with NASH. 20 patients enrolled. After a six month period, 90% of patients saw improvement, and fibrosis decreased in 50% of patients.

Breakthrough Device Designation

According to the FDA:

The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases…

The goal of the Breakthrough Devices Program is to provide patients and health care providers with timely access to these medical devices by speeding up their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the Agency’s mission to protect and promote public health.

Nonalcoholic Steatohepatitis (NASH)

Up to 25% of Americans have nonalcoholic steatohepatitis (NASH), a liver condition in non-drinkers (or those who rarely drink). In NASH, fat accumulates in the liver, causing inflammation, scarring, and damage. Risk factors for developing NASH include metabolic syndrome, high cholesterol, type 2 diabetes, and obesity. In fact, obesity accounts for an estimated 10 million NASH diagnoses in the United States. NASH mimics liver disease that affects heavy drinkers, although it is not always symptomatic. Those who do have symptoms may experience:

• Unintended weight loss
• Nausea and vomiting
• Appetite loss
• Jaundice (yellowing of the skin and eyes)
• Fatigue
• Confusion
• Pruritus (extreme itching)
• Abdominal pain
• Swelling of the lower extremities
• General weakness