Elipse Gastric Balloon
The Elipse Gastric Balloon is an inflatable balloon that is placed into the stomach to assist with weight loss.
The balloon is manufactured and marketed by Allurion, which gained European approval for the device in 2015, when it became the first non-endoscopic balloon to be offered to obese and overweight patients.
The company reports more than 40,000 balloon placements across 40 countries. The device is currently pending FDA approval in the United States.[1].
How the balloon works?[edit]
As with other intragastric balloons (IGB), the Elipse balloon works by filling space in the stomach. This creates a sense of fullness, reducing appetite and food intake [2]
Unlike many other gastric balloons, however, the Elipse solution does not require surgery, endoscopy or anesthesia for standard placement or removal. Placement takes place during a regular[3] outpatient consultation at a doctor’s surgery or weight-loss clinic.
The patient swallows a capsule that contains the deflated balloon. The capsule is connected to a thin catheter. Once swallowed, an X-ray is used to confirm that the balloon is positioned in the stomach. The balloon is then filled with 550 ml of water via the through the catheter. A follow-up X-ray is then conducted to finalise placement[3]. The procedure takes around 20 minutes.
Standard placement time is approximately 16 weeks. After that time, a self-activated release valve opens to empty the balloon. It then passes pass naturally through the gastrointestinal tract when the patient uses the toilet.
Efficacy[edit]
Clinical studies[2][4][5][6][7][8][9][10][11][12][13] indicate that patients can lose an average of between 10-15% of their body weight or 10 and 15kgs, during the recommended 16-weeks placement if combined with lifestyle modification.
One clinical stuffy reported by Ienca[5] et al. at 2020 Obesity Week showed that out of 509 patients, 95% of average weight loss was sustained 12 months after the completion of the balloon placement.
Safety[edit]
The Elipse balloon has been widely studied. The largest[5] study to date included 1623 patients across 19 healthcare centres in 7 countries and was found to be safe and effective.
Data indicates that 99.9%[5] of patients are able to successfully swallow the balloon during a standard placement. For those unable to swallow the capsule, the doctor uses the catheter to finalise placement.
In very rare cases, the Elipse balloon may require endoscopy or surgical intervention for removal. In a small number of cases, the patient has been reported to vomited rather than pass it via the instead of passing through the gastrointestinal tract. This, however, does not appear to result in any long-term side effects.
Sequential balloon placement[edit]
Depending on medical advice, it is possible to request a second balloon placement to facilitate further weight loss after the first placement has concluded. This is called a ‘sequential balloon’[14]. In one study, the average weight loss achieved after placing two balloons one after the other was 22 kilograms and 22.8% of total body weight. The maximum weight loss achieved was 48 kilograms or 40.9% body weight loss over a 12-month period.[11]
Lifestyle modification[edit]
Gastric balloons as weight-loss devices are most effective when they are combined with healthy eating programs and regular exercise.
The Allurion balloon is sold as part of a health and lifestyle program that includes dietary support from a nutritionist and various digital monitoring tools. One study showed that the balloon led to substantial weigh loss when it was used alongside a ‘lifestyle modification program’ that lasted for the entire placement In this case, 10% of patients achieved a total body weight loss of 72% after the 16 weeks compared to just 8% who used diet and exercise programs alone.[4]
References[edit]
- ↑ Businesswire. ‘Allurion Technologies Announces Submission of US Premarket Approval PMA Application for its Flagship Elipse’. Retrieved 20 February 2021
- ↑ 2.0 2.1 Jamal et al. Obes Surg. 2019 Apr;29(4):1236-1241
- ↑ 3.0 3.1 Clinical Trial Reports: DAA069 and DAA105
- ↑ 4.0 4.1 Raftopoulos et al. Abstract 1978. Presented at ACS 2019, San Francisco, United States.
- ↑ 5.0 5.1 5.2 5.3 Ienca et al. Abstract 237, presented at IFSO 2019, Madrid, Spain.
- ↑ Al Sabah, S., et al. SOARD. 2018, 14(3), 311-317.
- ↑ Machytka E et al. Endoscopy. 2017 Feb;49(2):154-160.
- ↑ Raftopoulos and Giannakou. SOARD. 2017 Jul;13(7):1174-1182.
- ↑ Genco et al. Obes Surg 2017,DOI 10.1007/s11695-017-2877-1.
- ↑ Al-Subaie S et al. Int J Surg. 2017 Dec;48:16-22.
- ↑ 11.0 11.1 Ienca et al. Submitted to SOARD. Abstract A278, presented at Obesity Week, 2018, Nashville, USA.
- ↑ Genco et al. Abstract A185. Oral Presentation at Obesity Week, 2018, Nashville, USA.
- ↑ Abu Dayyeh BK. Gastrointestinal Endoscopy. 2015; 82(3):425-438.
- ↑ Businesswire. ‘Allurion Technologies Announces New Clinical Data on the Elipse® Balloon at ObesityWeek® 2020.’ Retrieved: 25 February 2021.
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