Liver disease is a large and growing market globally.
Cirrhosis is late-stage liver disease which occurs when scar tissue (fibrosis) replaces healthy tissue. Alcohol and viral hepatitis B and C are common causes of cirrhosis, although there are many other cause including non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatis (NASH).
The incidence of liver disease and liver cirrhosis is increasing as a result of changing lifestyles, aging populations and more countries adopting western diets & lifestyles.
Chronic liver disease and cirrhosis is one of the fastest growing causes of death in the US, with liver cirrhosis estimated to be responsible for 2% of global deaths.
NAFLD (Non-alcoholic fatty liver disease) and NASH (non-alcoholic steatohepatis) are both closely associated with diabetes and obesity, and together are considered the number one cause of liver disease in Western countries.
NAFLD is fatty infiltrations in the liver not caused by alcohol which can then lead to NASH, a more serious stage of the disease where the liver becomes inflamed due to the accumulation of fat.
The excess build-up of fluid in the abdominal cavity, termed ascites, is a common complication among patients with late-stage liver disease, certain cancers and congestive heart failure. When ascites cannot be controlled with a special diet or medication, it is described as being ‘refractory’ to medical therapy, and the only option for the patient is to have the ascites removed periodically.
There are around 100,000 patients living with refractory ascites in Europe and the US. Refractory ascites is a growing problem, and the number of patients with the condition is increasing by about 10% per year due to a rise in the incidence of alcoholic and viral cirrhosis and a new population of patients with obesity-related liver disease.
The most common treatment for refractory ascites is paracentesis, an invasive procedure in which a large-bore needle is inserted into the abdomen, to drain the fluid over a period of a few hours. The alfapump® system offers patients suffering from refractory ascites with a completely new and much-needed treatment option for the management of their ascites.
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There are around 100,000 patients living with refractory ascites in Europe and the US.
Patients produce large volumes of ascites, 5, 1o, 15 or even 20 litres of ascites per week. Therefore as there normally is no extra space inside the abdominal cavity, so when large quantities of ascites accumulate in the abdominal cavity, the sheer volume of liquid puts pressure on the surrounding organs such as the bladder, stomach and even diaphragm. In addition to making it difficult to move around, common symptoms include fatigue, shortness of breath and some pain.
Pressure on the stomach can lead to loss of appetite and heartburn, ultimately resulting in malnutrition, and constant shortness of breath can limit a patient’s capacity to perform even minor everyday tasks.
Too much pressure inside the abdomen can lead to the development of hernias around the belly button or in the groin. Patients with ascites are also at high risk of other complications, such as severe internal infections and kidney problems.
Until the alfapump®, treatment options for refractory ascites have been limited and unsatisfactory for some patients, leaving both patients and doctors in need of a better solution.
Paracentesis is the removal of ascites from the belly via a large-bore needle inserted into the abdomen and the ascites is drained from the patient’s abdomen over a number of hours. Paracentesis is the most common treatment for refractory ascites worldwide.
However, paracentesis only offers temporary relief from ascites as it needs to be repeated when the ascites re-accumulates, often on a weekly or bi-weekly basis. In the meantime the patient is left feeling bloated and unwell as the fluid continues to collect, which together with the regular visit to the hospital severely impacts the patients’ quality of life. The repeated procedures are also a significant cost and burden on healthcare systems.
A TIPS (Transjugular Intrahepatic Portosystemic Shunt) is a shunt to re-route a significant proportion of the blood flow around the damaged liver into the main blood vessels.
The reduction in blood flow through the liver results in less filtering out of toxic substances in the blood stream and results in an increased risk of hepatic encephalopathy. In addition TIPS alone may not sufficiently control ascites. The use of TIPS is not recommended in patients with portal vein thrombosis, advanced liver failure, or heart failure.
65-year-old patient tells how her life has changed with the alfapump® system.
70-year-old patient talks about his recovered independence with the alfapump® system.