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Orbera US post-approval data

First data published on post-approval US Orbera balloon system

Average total body weight loss (TBWL) was 11.8% at six months, which is approximately 16% greater than that reported in Orbera’s US Pivotal Study

Apollo Endosurgery has announced the first publication from the Orbera US post-approval multi-centre study. This multi-centre study presents early results of the clinical use of Orbera in a commercial setting and is the first study of Orbera within the US population outside of clinical trials. The results are based on 321 patients treated at eight centres (three academic and five private) after FDA approval in August 2015. The primary effectiveness outcomes of the study were percent total body weight loss (TBWL) at three, six, and nine months. The study was published in the journal Clinical Gastroenterology and Hepatology.

Orbera is an incision-less, non-surgical weight loss solution designed for adult patients who are overweight or obese, who are not appropriate for or considering invasive surgery, but for whom diet and exercise or pharmaceutical interventions have not worked. In an 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 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 works with their physician and their staff in a formal lifestyle modification program to meet their long-term weight loss goals. Coaching takes place over 12 months, even though the balloon is removed after six months. The program is designed to help the patient develop sustainable, healthy habits that will help keep weight off over time.

Key data reported includes:

  • Average BMI at the time of Orbera placement of the 321 patients was 37.6.
  • Average total body weight loss (TBWL) was 11.8% at six months, which is approximately 16% greater than that reported in Orbera’s US Pivotal Study
  • Average weight loss of 25.1lbs at six months
  • At six months, TBWL of 5%, 10% and 15% was achieved by 88%, 62% and 31% of patients, respectively

In addition, the data showed a significant impact on obesity related comorbidities at six months:

  • 50% of type II diabetics stopped or decreased their medications and Haemoglobin A1C (HbA1C) was significantly improved by 0.7%
  • 45% of patients with hypertension were taken off their hypertension medications
  • No spontaneous inflations, pancreatitis, gastroesophageal perforations, or deaths were reported during the duration of follow-up

The study also highlights advances that may help improve the management of associated nausea and reduce the early removal rates due to these symptoms. The study showed a 35% reduction in the early removal rates compared to the US Pivotal study (18.8% vs. 12.3%). Additionally, the analysis identified two factors, usage of selective serotonin reuptake inhibitors and serotonin norepinephrine reuptake inhibitors for management of depression and usage of Aprepitant for nausea management, which were correlated to removal rates and that will help lead to further improvements of post-placement symptom management.

“The Orbera Intragastric Balloon is the worldwide market leading intragastric balloon and as shown in this first publication of real world clinical results from different centres in the US, has been delivering safe and effective weight loss for U.S. patients since its approval in August of 2015,” said Todd Newton, CEO of Apollo. 

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