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ASMBS endorsement

AspireAssist is endorsed by ASMBS

Receipt of endorsement means the device may be used in medical centres accredited by the MBSQUIP without having to obtain IRB approval

Aspire Bariatrics has received an endorsement from the American Society of the Metabolic and Bariatric Surgeons (“ASMBS”) for its AspireAssist system. The device consists of a low-profile implantable gastrostomy tube and a siphon system. Patients drain the contents of their stomachs after a meal, thereby reducing caloric absorption. The AspireAssist is given in conjunction with lifestyle therapy, in which patients are taught portion control, careful chewing, and other healthy lifestyle habits.

Receipt of endorsement of a device or procedure means that a device or procedure may be used in medical centres accredited by the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program without having to obtain Institutional Review Board approval.

The AspireAssist is intended for long-term duration of use, and is to be used in conjunction with diet and exercise counselling and medical monitoring. The device is implanted in a 15-minute outpatient procedure, is fully reversible and does not alter the patient’s internal anatomy. The system is indicated for obese patients, with a BMI35-55, who are age 22 or older and have failed to achieve weight loss using nonsurgical means. It's intended to be used for long-term weight loss and maintenance for a year or two or longer.

“We are grateful to the ASMBS for their hard work and diligence in their review of all the clinical data on the AspireAssist in reaching a positive endorsement decision,” said Dr Kathy Crothall, President & CEO of Aspire Bariatrics. “Endorsement of the AspireAssist is a huge milestone for Aspire and will help make AspireAssist therapy move available to patients with patients with body mass indexes 35 -55 who decline bariatric surgery or are not candidates for surgery.”

The device requires a surgeon to insert a tube in the stomach with an endoscope via a small incision in the abdomen. It connects to a disk-shaped port that lies on the skin of the abdomen. About 20 to 30 minutes after a meal, the patient attaches an external connector and tubing to the valve, which opens to drain the stomach contents. The process takes about five to 10 minutes.

It has an automatic shut-off feature that halts its functioning after 115 cycles of use; this requires the patient to make a physician visit to continue therapy and helps ensure that patients aren't misusing the device. There are a series of potentially risks associated with the placement of the tube, as well as the maintenance of the port valve. These include infection, leakage, bleeding, and persistent fistula development.

Patients use the AspireAssist to routinely dump almost one-third of their stomach contents after a meal directly into the toilet via a drain that it is implanted directly into the stomach. The idea is essentially the reverse of a traditionally placed feeding tube, only used outside the hospital for routine use after eating. The device is not to be used on patients with eating disorders.

“The AspireAssist procedure is the first endoscopic procedure endorsed by the ASMBS for patients with BMIs in excess of 40 or for patients who need a long-duration treatment,” said Dr Carson Liu, of SkyLex Health in Santa Monica, CA. “Endorsement of the AspireAssist by the ASMBS expands the armamentarium for treatment of obesity. There is a huge unmet need to provide safe and effective treatment alternatives to patients with obesity who either do not want or cannot have bariatric surgery.”

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