FDA approves Sequana Medical’s Alfapump for ascites treatment

FDA gives green light to innovative device for liver conditions

Sequana Medical NV has announced the US FDA approval of its Alfapump system for treating recurrent or refractory ascites due to liver cirrhosis.

This approval marks Alfapump as the first active implantable medical device for this condition in the US.

Professor H.E. Vargas of the Mayo Clinic expressed the significance of this approval: “The FDA approval of alfapump opens the door to a breakthrough therapeutic option for patients with ascites. This technology not only provides effective treatment but also improves quality of life.”

The company’s CEO, Ian Crosbie, also emphasised the milestone’s importance: “Today marks a huge milestone for the liver ascites community. Our vision is to transform the lives of these patients with a solution that allows them to take back their lives.”

The Alfapump system is designed to automatically and continuously move ascites from the abdomen to the bladder, eliminating the need for therapeutic paracentesis.

The POSEIDON study showed significant improvements in patient quality of life with the Alfapump system.

Sequana Medical plans to launch the Alfapump system commercially in the US in the second half of 2025, targeting liver transplant centers with a specialty sales force.

The company expects a market opportunity exceeding $2 billion by 2025, driven by conditions like NASH/MASH and alcoholic liver disease.

“We are highly encouraged by the feedback for the alfapump from the clinical community,” said Martijn Blom, Chief Commercial Officer. “Preparations for commercial launch are underway, and we are excited to establish alfapump as the new standard of care.”

Timur Resch, Global Vice President QM/QA/RA, added: “The PMA approval is a major milestone and reflects many years of diligent work. We thank the FDA for its collaboration in bringing this breakthrough device to US patients.”

The system has already been implanted in over 1,000 patients worldwide.