This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: AspireAssist
PMA Applicant: Aspire Bariatrics, Inc.
Address: 3200 Horizon Dr STE 100, King of Prussia, PA 19406
Approval Date: June 14, 2016
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf15/P150024a.pdf
What is it? The AspireAssist helps obese patients lose weight by draining a portion of the stomach contents after meals. The device consists of a tube that connects the inside of the stomach to a port (Skin-Port) outside of the abdomen. After eating, the patient attaches an external connector and tubing to the Skin-Port, opens the port valve, and drains the food -- before it has fully broken down and been absorbed by the body. Using this system, patients remove approximately 30% of the calories they consumed.
How does it work? The AspireAssist is used after each of the three daily meals. About 20 to 30 minutes after eating, the patient attaches the external components including the Companion, connector, tubing, and a water-filled reservoir. The stomach contents are drained by gravity into a toilet or other receptacle. After the initial draining is complete, the patient flushes the stomach with water by squeezing the reservoir and drains the stomach again.
When is it used? The AspireAssist is intended for adults who are at least 22 years old and are obese, with a Body Mass Index (BMI) of 35.0-55.0 kg/m2 who have failed to achieve and maintain weight loss with non-surgical weight loss therapy. The AspireAssist is intended for long-term use in conjunction with lifestyle therapy (to help patients develop healthier eating habits and reduce caloric intake) and continuous medical monitoring.
What will it accomplish? In a study conducted by the manufacturer, the group of people who used this device lost more weight than those who did not use it. The study included a total of 171 patients at 10 investigational sites in the United States. Of the 171 patients, 111 received the device and 60 did not receive the device. All study participants received diet and exercise counseling.
Patients with the device lost an average of 31.2 pounds (31.5% of their excess weight and 12.1% of their total body weight) after 52 weeks. The patients who did not receive the device lost an average of 9.0 pounds (9.8% of their excess weight and 3.5% of their total body weight) after 52 weeks.
The most common adverse events were related to the tubing implant site and included bleeding, irritation and infection. Other common adverse events include pain, nausea/vomiting, abdominal discomfort, and change in bowel habits.
When should it not be used?
The device should not be used in patients who
- Have had previous abdominal surgery that significantly increases the medical risks of gastrostomy tube placement
- Have esophageal stricture, pseudo-obstruction, severe gastroparesis or gastric outlet obstruction, inflammatory bowel disease
- Have a history of refractory gastric ulcers
- Have ulcers, bleeding lesions, or tumors discovered during endoscopic examination
- Have uncontrolled hypertension (blood pressure >160/100)
- Have a history or evidence of serious pulmonary or cardiovascular disease, including acute coronary syndrome, heart failure requiring medications, or NYHA (New York Heart Association) class III or IV heart failure
- Have coagulation disorders (platelets < 50,000, PT > 2 seconds above control or INR > 1.5)
- Have anemia (hemoglobin <8.0 g/dL in women and <10.0 g/dL in men)
- Are pregnant or lactating
- Are diagnosed with bulimia or binge eating disorder
- Have night eating syndrome
- Have chronic abdominal pain that would potentially complicate the management of the device
- Have a physical or mental disability, or psychological illness that could interfere with compliance with the therapy
- Are at high risk of having a medical complication from the endoscopic procedure or AspireAssist therapy weight loss program for any reason, including poor general health or severe organ dysfunction
Additional information (including warnings, precautions and adverse events): Summary of Safety and Effectiveness Data and labeling are available online: