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Orbera post-approval study

Patients enrolled in Orbera US post-approval study

The study will involve approximately 255 subjects at up to 20 US sites
Company launches the Orbera Coach platform, an on-demand telehealth program that provides virtual aftercare support tailored to meet the needs of patients who undergo the Orbera Gastric Balloon procedure

Apollo Endosurgery has announced the start of its US post-approval study of the Orbera Intragastric Balloon, a medical device used to assist obese adult patients (BMI30-40) in losing and maintaining weight. The first patient in the ‘Post-Approval Study Evaluating the Long-Term Safety and Effectiveness of Orbera’ was enrolled earlier this month in New Orleans, Louisiana, by the site’s lead investigator, bariatric surgeon Dr Rachel Moore.

“Orbera’s post-approval clinical study exemplifies Apollo’s commitment to offering safe and effective weight loss solutions to patients and their physicians in the United States,” said Moore. “The resulting data will help clinicians worldwide improve the treatment of obesity with a proven, minimally invasive option.”

The post-approval study is a prospective, multi-centre, open-label study designed to demonstrate the safety and effectiveness of Orbera as an adjunct to weight reduction for obese adults (22 years of age and older). The study will involve approximately 255 subjects at up to 20 US sites.

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. In a non-surgical (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, the Orbera balloon is deflated and then removed.

Once the balloon is in place, the patient receives an individually tailored support program through the Orbera Managed Weight Loss System team of experts to help keep them motivated, coordinate their program 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.

The US pivotal Orbera clinical trial first announced in May of 2015 was a multi-centre, prospective, randomised, non-blinded comparative study where a total of 255 patients suffering from obesity with BMI30-40 were randomised to treatment or control in a 1:1 ratio. The treatment group (125 patients) underwent placement of the Orbera balloon followed by removal after six months. They concurrently participated in a 12-month behavioural modification program. The control group (130 patients) 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.

Detailed findings from the trial include:

  • At month six, 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.

“Clinical confidence in medical devices comes from clinical evidence. Since Orbera’s inception, there have been over 230 peer-reviewed Orbera publications around the globe reporting on data of over 8,000 patients,” said Todd Newton, Chief Executive Officer of Apollo Endosurgery. “Retrospective and pivotal studies show, time and again, that Orbera is safe and effective, and helps patients lose the weight and also keep the weight off even after the device is removed. We believe the US post-approval study will add to this unmatched dataset.

In May 2016, the company launched the Orbera Coach platform, an on-demand telehealth program that provides virtual aftercare support tailored to meet the needs of patients who undergo the FDA-approved Orbera Gastric Balloon procedure. This telehealth aftercare program allows patients to access exercise, nutrition, and other coaching resources via on demand interaction with registered dietitians trained on the Orbera procedure during the 12-months following placement of the Orbera gastric balloon. Orbera Coach patients can interact anytime, anywhere via face-to-face live video conferencing, including one-to-one, group and webcast scheduled or on-demand.

Utilising Zillion technology, the program also facilitates group discussion sessions, weight loss tracking, a personal journal to monitor and reflect on progress, a collection of recipes and meal plans geared toward healthy eating and a health and wellness content library. Orbera Coach provides significant data for the physician to assist in managing patients who have undergone an Orbera procedure.

“Minnesota Gastroenterology has had a Weight Management & Nutrition Program for the past several years. What we are excited to see with Orbera Coach is that it includes much of what our program offers but at a lower cost and with much greater flexibility in patient scheduling,” said Dr David Feldshon Minnesota Gastroenterology, PA. “Educational modules are now immediately available to patients to review at their leisure and dietary recommendations are tailored specifically to the balloon procedure. With an electronic database that makes patient follow up much easier, Orbera Coach should be a valuable tool to accompany placement of the gastric balloon for any practice.”

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