Automated Low-Flow Ascites (ALFA) Therapy

Ascites is fluid that accumulates in the peritoneal (abdominal) cavity and can be a symptom of liver cirrhosis, congestive heart failure and certain types of cancers. For most patients, ascites accumulation is managed through diuretics and dietary restriction. Refractory ascites is ascites accumulation that is unresponsive to diuretic therapy. Up to 10% of all patients with ascites fall into this category. Over 100,000 patients suffer from refractory ascites in Europe and the USA every year.

The symptoms associated with ascites can be painful and distressing. As patients accumulate fluid, the abdomen becomes very swollen and distended making it difficult to get comfortable when sitting up or walking. Symptoms include tiredness, lethargy and shortness of breath. Elevated intra-abdominal pressure can lead to the development of umbilical (around the bellybutton) and inguinal (groin) hernias. Patients with ascites are at high risk of peritoneal infection and hepatorenal syndrome.

Refractory ascites is most commonly treated with paracentesis, a procedure where ascites is drained over a period of hours through a large-bore needle inserted into the abdomen. This procedure must be repeated when ascites reaccumulates, often on a weekly or bi-weekly basis. Some cirrhosis patients can be treated with the implantation of a transjugular intrahepatic portosystemic shunt (TIPS), which allows some of the blood to bypass the liver thereby reducing high portal vein pressure. TIPS often reduces ascites accumulation but carries risk of significant side effects including debilitating encephalopathy which develops in 30% of patients due to the loss of the liver’s ability to remove toxins from the blood that bypasses the liver through the TIPS.

The ALFA Therapy enabled by the NovaShunt Pump System is a new treatment option for patients with refractory ascites. Removing ascites as it forms prevents the massive accumulation of ascites and related symptoms and dramatically reduces the need for paracentesis. Patients that have received the ALFA Therapy have improved their nutrition and become more active. Better management of ascites using the ALFA Therapy will both improve patient quality of life and reduce healthcare costs.

“I’m very satisfied how the patient improved over the last 6 months. He did not have any paracentesis, did not need any albumin supplement and takes diuretics only as necessary. It was very interesting to see that over time he did start responding to diuretics although he was refractory prior to the implant of the NovaShunt Pump System.”

Dr. Marek Benes, IKEM Hospital, Prague, Czech Republic

The NovaShunt Pump System is an investigational device, limited to research use and is not available for sale.