King of Prussia’s Aspire Bariatrics has received approval from the Food and Drug Administration for its obesity treatment device that uses a surgically placed tube to drain a portion of the stomach contents after every meal.
Aspire Bariatrics has spent the past six years developing its AspireAssist device and already sells it in some European countries, writes John George of the Philadelphia Business Journal.
“This is a huge deal for us,” said Katherine D. Crothall, CEO of Aspire. “This opens us up to the largest market for obesity devices, which is the United States. The second thing it does is add credibility to our product and procedure.
“It’s fair to say worldwide the medical community looks at the FDA as having the most rigorous approval process. The assumption is if the FDA approves a product, it’s safe and effective. This will help us in the United States and outside the United States as well.”
According to George, Crothall said AspireAssist provides patients with a body mass index above 35 with a less invasive and reversible alternative to bariatric surgery procedures that reduce the size of a person’s stomach.
In approving the device, the FDA said it should not be used on patients with eating disorders, and it is not intended to be used for short durations in those who are moderately overweight. The federal agency said AspireAssist is intended to assist in weight loss in patients aged 22 and older who are obese, with a body mass index of 35 to 55, and who have failed to achieve and maintain weight loss through nonsurgical weight-loss therapy.
“The AspireAssist approach helps provide effective control of calorie absorption, which is a key principle of weight management therapy,” said Dr. William Maisel, deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health. “Patients need to be regularly monitored by their health care provider, and should follow a lifestyle program to help them develop healthier eating habits and reduce their calorie intake.”
Click here to read more about Aspire Bariatrics in the Philadelphia Business Journal.