Aspire Bariatrics has received approval from the US Food & Drug Administration (FDA) for its AspireAssist obesity device.
AspireAssist system is an endoscopic alternative to weight loss surgery for people with moderate to severe obesity.
It is indicated for adults with a BMI of 35 to 55 who have not succeeded with more conservative therapies.
AspireAssist system, which offers a novel approach to obesity treatment through portion control, can be used in conjunction with diet and exercise counselling and medical monitoring.
The system can be implanted in a 15-minute outpatient procedure. It is fully reversible, and does not alter the patient’s internal anatomy.
The company assessed AspireAssist in the Pathway study, a 171-subject multicenter trial in the US.
Patients lost an average of 46 pounds in the first year in a previous randomized US clinical study with the AspireAssist system.
Aspire Bariatrics president and CEO Katherine Crothall said: "We are very happy to be able now to offer this life-changing therapy in the US to patients with obesity; many of whom felt, until now, that there were few viable solutions for them."