The AspireAssist is intended to assist in weight reduction of obese patients. It is indicated for use in adults aged 22 or older 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 a long-term duration of use in conjunction with lifestyle therapy and continuous medical monitoring.
The AspireAssist is not recommended for patients who have certain disorders that cause extreme difficulty swallowing or digesting food, previous stomach ulcers that do not resolve with treatment, previous radiation therapy to the chest or abdomen, high blood pressure than cannot be controlled with medication (blood pressure >160/100), blood clotting disorders, bulimia, binge eating disorder, or night eating syndrome, anemia, serious pulmonary (lung) or cardiovascular disease, chronic abdominal pain, or for patients who are pregnant or lactating. The AspireAssist is also not recommended for patients with previous abdominal surgery that significantly increases the medical risks of gastrostomy tube placement, or for patients with physical or mental disability, or psychological illness that could interfere with compliance with the therapy.
03: Adverse Events
In the US Clinical Study, the most common adverse events immediately after the procedure were abdominal discomfort or pain (treated with pain medication), and nausea or vomiting related to the sedation medicine given during the procedure (treated with anti-nausea medication, if necessary).
The most common adverse events related to the device or therapy were skin irritation or granulation tissue around the tube placement site on the abdomen (treated with silver nitrate sticks or medicated lotion). Other less common side effects include infection (treated with antibiotics, or device removal or replacement) and abdominal pain or discomfort (treated with medication).
In the clinical study 3.6% of patients (4 out of 111 patients) experienced a Serious Adverse Event, which included any event requiring an overnight hospital stay, or that could potentially lead to serious harm. These four events were peritonitis (abdominal tissue inflammation, which can lead to infection or severe pain), abdominal pain post-procedure, tube replacement due to normal wear, and non-bleeding pre-pyloric ulceration (sore on the inside of the stomach, which can result in pain). All of these adverse events were successfully treated with medication, or tube replacement or removal. There were no deaths in the study, and no adverse events that required surgical treatment.
Full complete safety information, please see the Instructions for Use or talk to your doctor.