The alfapump system, developed by Sequana Medical, has demonstrated significant efficacy in managing ascites and improving the quality of life for patients with decompensated cirrhosis. Data from the pivotal POSEIDON study, recently published in the American Journal of Gastroenterology, highlights the system's ability to reduce or eliminate the need for therapeutic paracentesis, a burdensome procedure for patients with recurrent or refractory ascites.
The POSEIDON study, a multicenter, open-label, single-arm trial, involved 40 patients with cirrhosis and recurrent or refractory ascites. The study's six-month data revealed that the alfapump system effectively controlled ascites, leading to a notable improvement in patients' quality of life. This improvement included an average of 10 additional good health days per month, a significant benefit for patients whose lives are often severely impacted by their condition.
Clinical Impact and Quality of Life
Professor Florence Wong, a principal investigator for the POSEIDON study and Hepatologist at Toronto General Hospital, emphasized the impact of recurrent ascites on patients' lives. "Patients with recurrent or refractory ascites have a very poor quality of life, and reliance upon large volume paracentesis (LVP) imposes a substantial burden on them, as well as their caregivers and the health care system," she stated. "The results from the POSEIDON study in this publication have shown that the alfapump system effectively controlled ascites, which improved quality of life, with complication rates similar to the expectation in patients with refractory ascites at six months post-implantation."
Survival and Safety
Importantly, the study also indicated that the overall survival of patients using the alfapump was not worse compared to Transjugular Intrahepatic Portosystemic Shunt (TIPS) and was higher than reported for standard of care (LVP). The safety profile of the alfapump was consistent with what is typically observed in this patient population.
Market and Future Plans
The US market for recurrent and refractory ascites due to liver cirrhosis is projected to expand from approximately 70,000 patients in 2025 to 130,000 by 2032, driven largely by the increasing prevalence of NASH/MASH. Sequana Medical estimates the total market opportunity for alfapump to be over $2 billion in 2025.
Following FDA approval in December 2024, Sequana Medical is actively preparing for the US commercial launch of the alfapump system in the second half of 2025. This launch aims to provide a much-needed alternative for patients with diuretic-resistant fluid overload, a condition that significantly diminishes their quality of life and places a heavy burden on healthcare systems.
Dr. Gijs Klarenbeek, Chief Medical Officer of Sequana Medical NV, commented on the publication and future plans: "We are delighted with this thoughtful publication of the six month results from our POSEIDON study, and we thank all of the investigators and study teams... Following the alfapump’s US FDA approval in December, we are stepping up our preparations for US commercial launch planned for H2 2025."
