The Pioneer clinical study conducted by Sequana Medical demonstrated the safety and efficacy of its automated low-flow ascites pump (ALFApump) system for the management of ascites in patients with advanced cirrhosis.
ALFApump features a subcutaneously implanted battery-powered pump connected to a catheter placed in the abdominal cavity, which automatically and continually collects ascites and moves it to the bladder, where it is eliminated from the patient through normal urination.
Pioneer was a prospective multicentre open label study which enrolled patients with refractory ascites due to liver cirrhosis at nine centres in four European countries, demonstrating that the system is safe and effective for management of ascites.
In addition to safety and efficacy data, the study reported that ALFApump considerably reduced the median number of paracentesis procedures from 3.4 a month prior to pump implant to just 0.2 a month, plus there was a 91% reduction in the volume removed by paracentesis.
Noel Johnson, Sequana Medical CEO, said the ALFApump system was developed to benefit both patients and physicians in managing refractory ascites.
"I am quite pleased that the EASL Board selected the abstract describing the initial data from the ALFApump Pioneer study for oral presentation at this year’s International Liver Congress," Johnson added.
Jose Such, hepatology chief at the Hospital General, University de Alicante, Spain, said the system was proven to be a safe and efficacious device which will improve lives of thousands of patients with refractory ascites by freeing them from the burden of repeat visits to the hospital for paracentesis.
In July 2011 ALFApump was granted the CE mark, and it is currently being introduced into leading hepatology centres across Europe.
Sequana Medical is a Swiss medical device company aimed at improving patient lives through innovative technologies to manage fluid overload in patients suffering from liver disease, cancer and congestive heart failure.