Aspire Bariatrics files PMA application at FDA for AspireAssist as alternative to weight loss surgery
Aspire Bariatrics announced that it has submitted to the FDA a Pre-Market Approval (PMA) application of its lead product the AspireAssist Aspiration Therapy System, an endoscopic alternative to weight loss surgery. The AspireAssist is the first endoscopically-placed device to meet its primary endpoints in a randomised, controlled pivotal trial for weight loss for people with body mass index (BMI) of 35–55 kg/m2. The PMA submission included one-year data from the PATHWAY study, a randomised, controlled pivotal trial of 171 subjects at ten leading medical centers across the USA.
Comment: With aspiration therapy, patients 'aspirate' (drain) a portion of their stomach contents into the toilet after each meal through an endoscopically-implanted tube, reducing the number of calories absorbed by the body. The tube is implanted in the stomach, and leads to a small, low-profile port at the surface of the skin. Aspiration performed about twenty minutes after a meal will remove about a third of the calories consumed.
Comment: AspireAssist already has a CE Mark.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.