Automated Low-Flow Pump Removes Ascites

The system is comprised of a subcutaneously implanted battery powered pump that is connected to a catheter placed in the abdominal cavity, and another catheter connected to the bladder. The system automatically and continually collects fluid as it forms in the abdominal cavity and moves it to the bladder, where it is eliminated through normal urination; a single charge of the system is enough to move five liters of ascites.

The ALFApump is recharged wirelessly through the skin, and can also be wirelessly programmed by the attending physician. Implantation can be performed under local or general anesthesia (GA), and takes about 45 minutes. The system is a product of Sequana Medical (Zug, Switzerland), and has received the Conformite Europeenne (CE) marking.

“This is a major milestone both for our company and for patients with refractory ascites,” said Noel Johnson, MD, CEO of Sequana Medical. “For patients, the treatment options for refractory ascites have been very limited and carried significant risks and side effects. The ALFApump System offers a new treatment tool, which can improve patient quality of life while also reducing hospitalizations. It is a cost-effective solution and we believe over time it will become the preferred option for patients, physicians, and payers.”

“The benefits of the ALFApump System are entirely aligned with the goals of patients, physicians and payers,” added Dan Rose, VP of commercial operations at Sequana Medical. “The system is designed to offer patients better clinical outcomes and quality of life while eliminating the requirement for repeated expensive and burdensome invasive procedures.”

Refractory ascites occurs when patients with ascites no longer respond to medical therapy, a condition that affects over 100,000 patients in Europe and the United States every year; that number is growing at approximately 10% a year due to the accelerating incidence of hepatitis- and obesity-related liver disease. The primary treatment for ascites is paracentesis, a procedure in which a large bore needle is inserted into the patient's abdomen to remove between 5-10 liters of ascites that has accumulated over a period of a week or two.

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