Sequana Medical NV has announced that the U.S. Food and Drug Administration (FDA) has accepted its Premarket Approval (PMA) application for the alfapump® for substantive review. This device is intended for patients suffering from recurrent or refractory ascites due to liver cirrhosis. The acceptance indicates that the FDA considers the application complete enough to warrant an in-depth review.
The alfapump® is a fully implantable, wirelessly charged device designed to automatically and continuously remove ascites from the abdomen into the bladder, where it is naturally eliminated through urination. It received breakthrough device designation from the FDA in 2019.
The PMA application is based on the results of Sequana Medical’s pivotal POSEIDON study, conducted across 18 centers in the US and Canada. The study involved 69 patients implanted with the alfapump®. At six months post-implantation, the primary effectiveness endpoints exceeded predefined thresholds with statistical significance, and the primary safety endpoint data aligned with expectations. Twelve-month data demonstrated a sustained clinical profile, significantly reducing the need for therapeutic paracentesis and improving patients’ quality of life.
Clinical Data and Patient Preference
Data from the POSEIDON study showed that the alfapump® virtually eliminated the need for therapeutic paracentesis and delivered a clinically meaningful improvement in patients’ quality of life. A patient preference study and a matched cohort analysis of the NACSELD registry indicated a strong preference for the alfapump® over standard paracentesis procedures and a comparable safety profile.
Market Opportunity
The North American market for recurrent and refractory ascites due to liver cirrhosis is projected to grow by 6-7% annually, reaching a market opportunity of over $2.5 billion by 2035. NASH (nonalcoholic steatohepatitis) is expected to be a major driver of this growth. To date, over 1,000 alfapump® systems have been implanted.
Current Treatment Landscape
Currently, the standard treatment for recurrent or refractory ascites involves therapeutic paracentesis, an invasive procedure that drains fluid from the abdomen using a large needle. The alfapump® offers a potential alternative by automatically and continuously removing ascites, potentially reducing the burden on patients and healthcare systems.
Company Comments
Timur Resch, Global Vice President QM/QA/RA at Sequana Medical, stated, “The acceptance of our PMA file for substantive review by the FDA is an important milestone that reflects the tremendous efforts of our team... We look forward to working closely with the FDA during the review process, with the ultimate goal of making the alfapump® available to US patients as soon as possible.”
Sequana Medical anticipates FDA approval in the second half of 2024, which could make alfapump® the first active implantable medical device available in the US for treating liver ascites.
