Sequana Medical is pleased to announce that it has received CE mark approval for use of its alfapump® system in patients with ascites caused by cancer (malignant ascites). The alfapump® system was first introduced to the European market last year for patients with refractory ascites caused by advanced liver disease. The system is fully implantable, and automatically and continually collects ascites from the abdominal cavity and moves it to the bladder, where it is excreted naturally from the body.
Malignant ascites is an excess build-up of fluid in the abdominal cavity and is a common complication among patients with ovarian, pancreatic and gastric cancer. It is usually managed with large-volume paracentesis, an invasive hospital-based procedure in which the ascites is drained over a number of hours through a large-bore needle inserted in the abdomen.
"CE mark approval of the alfapump® system for patients with malignant ascites is a major milestone for Sequana Medical", stated Noel L. Johnson, President and CEO of Sequana Medical. "Malignant ascites affects more than 20,000 people per year in the EU. Our system was designed to improve quality of life, so we are very pleased indeed that cancer patients with ascites will now also be able to benefit from our technology."
Patients no longer experience the discomfort of chronic ascites accumulation and they no longer have to make regular trips to the hospital for paracentesis. By decreasing hospitalization time, the alfapump® system reduces the burden of ascites for patients, physicians and the healthcare system.