FDA Approves AspireAssist Obesity Device
On June 14, 2016, the U.S. Food and Drug Administration approved AspireAssist, an obesity treatment device that uses a surgically-placed tube to drain a portion of the stomach contents after every meal. According to a press release by the manufacturer Aspire Bariatrics, the AspireAssist System is an endoscopic alternative to weight loss surgery for people with moderate to severe obesity and is indicated for adults with a BMI of 35 to 55 who have not succeeded with more conservative therapies.
The FDA news release summarized the procedure of installing and using AspireAssist as follows:
To place the [AspireAssist] device, surgeons insert a tube in the stomach with an endoscope via a small incision in the abdomen. A disk-shaped port valve that lies outside the body, flush against the skin of the abdomen, is connected to the tube and remains in place. Approximately 20 to 30 minutes after meal consumption, the patient attaches the device’s external connector and tubing to the port valve, opens the valve and drains the contents. Once opened, it takes approximately five to 10 minutes to drain food matter through the tube and into the toilet. The device removes approximately 30 percent of the calories consumed.
According to the FDA news release, the FDA reviewed results from a clinical trial of 111 patients treated with AspireAssist and appropriate lifestyle therapy and 60 control patients who received only the lifestyle therapy. The lifestyle therapy included nutrition and exercise counseling. After one year, patients who used AspireAssist lost an average of 12.1 percent of their body weight compared to 3.6 percent for the control patients. Clinical trial results also suggested that both patient groups had small improvements in conditions often associated with obesity, such as diabetes, hypertension and quality of life.
A youtube video on the AspireAssist System published by Aspire Bariatrics is attached below:
FDA Approves EnteroMedics’ Implantable Obesity Treatment Device
St. Paul, MN-based EnteroMedics Inc. recently announced that the Food and Drug Administration (FDA) approved the use of its VBLOC vagal blocking therapy, delivered via its Maestro system. The system is indicated for treatment of obese adults having a Body Mass Index (BMI) of at least 40 to 45 (units of Kilogram per Meter squared), or a BMI of at least 35 to 39.9 with a related health condition such as high blood pressure or high cholesterol levels, and who have already tried to lose weight in a supervised weight management program within the past five years. A news release by the FDA further noted that the Maestro System is the first obesity treatment device to be approved by the FDA since 2007.
According to the Wall Street Journal, the Maestro system disrupts signals between the stomach and brain by blocking electrical signals in the abdominal vagus nerve through the use of high-frequency electrical pulses. The FDA reported that the Maestro System was evaluated in a 233-patient clinical study where the experimental group lost about 8.5% more of its excess weight than the control group in a 12 month period. The FDA further reported that about half (52.5%) of patients in the experimental group lost at least 20% of their excess weight, and 38.3% of the experimental group lost at least 25%. According to NBCnews, as part of the approval process, EnteroMedics must conduct a five year post approval study following at least 100 patients to collect additional safety and effectiveness data.
According to its website:
EnteroMedics® is committed to the delivery of safe, effective and sustainable therapies that address the growing global health crises associated with the increased prevalence of obesity and metabolic diseases, including diabetes and hypertension. EnteroMedics is rapidly advancing its novel technology, VBLOC® vagal blocking therapy delivered via the Maestro® Rechargeable System, to broadly benefit patients, health care providers and stakeholders around the world.
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