|Orbera Intragastric Balloon--Courtesy of Apollo|
The marketer of the Lap-Band, the most successful medical device marketed in the U.S. to aid weight loss, has gained an FDA approval for what it hopes will lead the next wave of obesity devices--the Orbera Intragastric Balloon.
Apollo Endosurgery's Orbera was approved by the FDA to assist obese adults with a body mass index of 30 to 40 to lose and maintain weight. That makes it the third obesity approval from the agency already this year. Another balloon-based device was approved last week for privately held ReShape Medical, while a controversial neurostimulation implant from EnteroMedics ($ETRM) gained approval earlier this year.
"For many, the weight loss journey leaves patients with little support or options other than diet and exercise and traditional surgery, bariatric surgeon," Dr. Christine Ren-Fielding commented in a statement from Apollo. "The approval of Orbera fills this gap in available treatments and is an exciting development for healthcare professionals who are committed to providing patients with less invasive options that can assist them in reaching their long-term weight loss goals."
The FDA first approved the Lab-Band in 2001. Apollo acquired that device, as well as the then-investigational device Orbera, for a price of up to $110 million in December 2013 from Allergan ($AGN).
There are now a total of 5 FDA-approved obesity devices. The novel obesity drugs approved by the FDA in recent years have failed to generate significant sales due to middling efficacy and the resulting lack of payer reimbursement. So device companies are hopeful that they can offer a middle ground in the U.S. that provides more efficacy than drugs.
At the end of last month, another startup, Aspire Bariatrics also submitted a PMA application to the FDA for an obesity device; this one works by enabling the patient to physically drain digesting food from the stomach into a toilet via a port. However, another obesity startup, Australian GI Dynamics, terminated its U.S. pivotal trial last week due to safety concerns involving the rate of liver infections with its gastric liner device.
For its part, Apollo claims that it's already the leader ex-U.S. in intragastric balloons to treat obesity, having placed more than 220,000 of the devices already for patients in more than 80 countries.
The endoscopic placement of Orbera typically takes 20 to 30 minutes under a mild sedative; the deflated balloon is inflated with saline once it's placed in the stomach to about the size of a grapefruit.
The FDA approval for Orbera is also a bit broader than the indication that competitor ReShape gained. Both indications are confined to obese adults with a BMI of 30-40 kg/m2--but those for ReShape's balloon system must also have an obesity-related condition such as diabetes, high blood pressure, or high cholesterol. Both of these balloon devices are limited to 6 months of use, with ReShape's device consisting of two balloons compared to only one with Orbera.
In the clinical data cited by the FDA in its Orbera approval, patients lost an average of 21.8 pounds (10.2% of their body weight) after 6 months, better than the 7 pounds lost on average by trial patients who only participated in a behavior modification program. That average weight loss with the balloon moderated by 3 months after it was reduced to 19.4 pounds on average.
That's a bit better than the ReShape data in which a similar obese patient population, but also with at least one obesity-related health condition, shed 14. 3 pounds (6.8% of body weight) on average after 6 months.
- here are the Apollo and the FDA releases