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FDA approves Orbera Balloon

FDA approves Apollo's Orbera Intragastric Balloon

US trial results showed that patients who received the Orbera balloon lost 3.1 times as much weight as the control group at six months

The FDA has approved Apollo Endosurgery’s Orbera Intragastric Balloon to assist adult patients suffering from obesity (BMI30-40) in losing and maintaining weight. The Orbera balloon is part of the Orbera Managed Weight Loss System, a non-surgical two-part programme that includes a balloon filling space in a patient’s stomach to reinforce proper portion control. Orbera is an incision-less, non-surgical weight loss solution designed for adult patients suffering from obesity, who are not appropriate for or considering invasive surgery, but for whom diet and exercise or pharmaceutical interventions have not worked.

“For many, the weight loss journey leaves patients with little support or options other than diet and exercise and traditional surgery. 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,” said Dr Christine Ren-Fielding, a New York-based bariatric surgeon. “Orbera gives us a new weight loss option to help address what has become a critical health issue in the US.”

In the endoscopic procedure, the thin and deflated Orbera balloon is placed into the stomach. It is then filled with saline until it’s about the size of a grapefruit. The procedure typically takes about 20 to 30 minutes and the patient can generally go home the same day. At six months, through another non-surgical procedure done under a mild sedative, the Orbera balloon is deflated and then removed.

Once the balloon is in place, the patient receives an individually tailored support programme (through the Orbera Managed Weight Loss System team of experts) which may include a dietician, psychologist and exercise physiologist to help keep them motivated, coordinate their programme and help them work through weight loss barriers to meet their long-term weight loss goals. Coaching takes place over 12 months, even though the balloon is removed after six months. The programme is designed to help the patient develop sustainable, healthy habits that will help keep weight off over time.

In the US pivotal Orbera clinical trial, a multi-centre, prospective, randomized, non-blinded comparative study, patients suffering from obesity with a BMI between 30-40 were randomized to treatment or control in a 1:1 ratio. The treatment group underwent placement of the Orbera balloon followed by removal after six months. They concurrently participated in a 12-month behavioural modification programme. The control group participated in the 12-month behavioural modification programme alone. For patients in the treatment group, the device was removed at month six, with regular office visits continuing through one year.

A total of 125 patients were randomised to the treatment group and 130 patients were randomized to the control group. At month six, the outcomes revealed:

  • The Orbera group achieved a mean of 38.4 percent Excess Weight Loss (EWL)
  • Mean Total Body Weight Loss (TBWL) at six months was 10.2 percent for the treatment group compared to 3.3 percent TBWL for the control group
  • The Orbera group lost 3.1 times as much weight as the control group at six months
  • The Orbera group also lost significantly more weight than the control group over the course of the study, and was able to maintain significant weight loss through month 12, six months after removal of the device

“While new to the US, Orbera is a weight loss device with more than 220,000 balloons distributed in over 80 countries and approximately 230 published papers documenting its clinical results,” said Todd Newton, Chief Executive Officer of Apollo Endosurgery. “Orbera is a proven, innovative and non-surgical solution to help fight the obesity epidemic and treat patients before their disease progresses and requires more invasive treatments. With the FDA approval of Orbera, Apollo can now offer this safe and effective solution to patients and their physicians in the US.”

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