|A still shot from a video of Aspire Bariatrics's AspireAssist Aspiration Therapy--Courtesy of Aspire|
A device to treat obesity, although it may be a bit difficult to stomach, is headed for an FDA submission in June 2015. Aspire Bariatrics has completed enrollment of a pivotal trial for its AspireAssist Aspiration Therapy and plans to submit a PMA then. This device isn't alone; several obesity devices are aiming for an FDA review within the next year or two.
The aspiration therapy is intended to treat obese patients with a BMI of 35 to 55. The idea is to drain some of the stomach contents after a meal, thereby reducing calorie consumption by about 30%.
First, a thin tube is placed in a 20-minute outpatient surgical procedure. It runs from the stomach to the surface of the skin. Then about 10 days later, once the wound has healed, the physician attaches a poker-chip-sized skin-port to the tube on the skin several inches above the patient's belly button, a process that can be done in the doctor's office. The procedure is similar to a percutaneous endoscopic gastrostomy, in which patients who cannot eat are tubed in order to receive nutrients directly into the stomach.
The AspireAssist patient then uses a small handheld device to empty about one-third of their stomach contents into the toilet about 20 minutes after a meal is completed. Not an entirely appetizing after-dinner prospect; the process takes 5 to 10 minutes.
Patients who regularly aspirate lose about 40% of their excess weight by the end of 6 months, according to the company.
The U.S. PATHWAY pivotal trial for AspireAssist completed enrollment in June with 171 patients at 10 clinical sites. Patients were randomized two to one into treatment or control groups; both groups get lifestyle counseling, but that is all the control group receives. Trial sites include Boston University Medical Center, Brigham and Women's Hospital, Cornell University, Howard University, the Mayo Clinic, Northwestern University, St. Mary Medical Center, University of Pennsylvania, the Veterans Affairs San Diego Healthcare System and Washington University.
|Dr. Louis Aronne|
"With less than 1% of patients who meet the eligibility requirements for bariatric surgery actually electing to undergo bariatric surgery, there is clearly a need for alternative approaches that are safer, less invasive, reversible, less intrusive on patients' daily life, affordable to the healthcare system and patients, and suitable for long-term therapy," Dr. Louis Aronne, co-principal investigator in the study and a professor of metabolic research at Weill-Cornell Medical College, said in a statement. "The AspireAssist may help to address this unmet need."
Aspire received a CE mark for the device in December 2011; the company is starting postmarketing studies in Italy, United Kingdom, Austria and Germany as well as continuing postmarket testing in Sweden, Czech Republic and Spain.
Aspire is one of several obesity device companies aiming for a U.S. approval. ReShape Medical recently submitted a PMA to FDA for its balloon-based obesity device, while EnteroMedics garnered a mixed FDA panel vote in June for its neurostimulator obesity device. EndoBarrier and USGI Medical are also in pivotal trials for each of their endoscopic obesity devices.
- here is the press release