Sequana Medical's ALFApump System safe and effective in managing ascites

Sequana Medical announced that initial results from the PIONEER Clinical Study of its ALFApump System were presented today at the 47^th annual European Association for Study of the Liver Meeting in Barcelona. The data demonstrated that the ALFApump System is a safe and effective device for management of ascites in patients with advanced cirrhosis. The PIONEER study is a prospective, multi-centre, open label study of patients with refractory ascites due to liver cirrhosis conducted at nine centres in four European countries. Sequana Medical's ALFApump System is the first and only system for the automatic and continual removal of ascites. Refractory ascites affects over 100,000 patients in Europe and the US every year and the number of patients is growing at an annual rate of 10% due to the accelerating incidence of hepatitis and obesity-related liver disease.    

Dr. Jose Such, Chief of Hepatology at the Hospital General, University de Alicante, Spain, presented initial data in a session entitled "Description of an Automated Low-Flow Ascites (ALFA) pump system for the treatment of ascites in patients with cirrhosis. Preliminary Report". In addition to safety and efficacy, the data showed that the ALFApump System significantly reduced the median number of paracentesis procedures from 3.4 in the month prior to pump implant to just 0.2 per month and there was a 91% reduction in the volume removed by paracentesis.

Ascites is a common complication among patients with late-stage liver disease and is the leading reason for hospitalization among patients with cirrhosis. Paracentesis, which involves inserting a large-bore needle into the abdomen to drain 5-10 litres of accumulated ascites, is the most common procedure for the treatment of ascites. However, paracentesis has to be repeated frequently, often every 7-10 days, as it doesn't prevent the re-accumulation of ascites. This repeated procedure is burdensome both to the patient and healthcare service provider.

"The ALFApump System was developed to bring significant benefits to both patients and physicians, and has the potential to become the new standard of care for management of refractory ascites", said Dr. Noel L. Johnson, CEO of Sequana Medical. "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."

The ALFApump System consists of 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.

"I am delighted to have had the opportunity to present these promising results from the Pioneer Study at the EASL congress", stated Dr. Jose Such. "The ALFApump System is proving to be a safe and efficacious device that will improve the lives of thousands of patients with refractory ascites by freeing them from the burden of repeat visits to the hospital for paracentesis."