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Sequana Medical ALFApump System receives CE mark approval

Sequana Medical, a provider of technologies to manage fluid within the body, has received CE mark approval for ALFApump System.

ALFApump System is an implantable pump system designed to remove excess abdominal fluid, known as ascites, in patients suffering from liver cirrhosis.

The system features a subcutaneously implanted battery-powered pump with a catheter placed in the abdominal cavity and another catheter connected to bladder where it collects fluid and eliminates through normal urination.

Sequana Medical Commercial Operations VP Dan Rose said the system is designed to offer patients clinical outcomes and quality of life while eliminating the requirement for repeated expensive and invasive procedures.

"The performance of the ALFApump System in the PIONEER Clinical Study has surpassed our expectations and indicates a new treatment option for our technology," Rose said.

Sequana Medical has appointed Farzana Malik as its Market Access and Reimbursement vice president.

Malik previously worked in Alexion Pharmaceuticals as head of Pricing and Market Access and also worked at Merck Serono, Medtronic and Pfizer.

Sequana Medical CEO Noel Johnson said Malik is a Health Economist and brings over 15 years expertise in developing and executing health economics, pricing and reimbursement strategies in the biotechnology, pharmaceutical and medical device industries.