Sequana Medical NV has announced that the US Food and Drug Administration (FDA) has granted Premarket Approval (PMA) to market its Alfapump® system for the treatment of recurrent or refractory ascites due to liver cirrhosis. This approval marks a significant milestone, as Alfapump becomes the first active implantable medical device in the US to automatically and continuously remove ascites from the abdomen into the bladder for natural elimination.
Clinical Significance
Ascites, characterized by the accumulation of fluid in the abdomen, is a severe condition often resulting from liver cirrhosis. Current standard treatment involves therapeutic paracentesis, an invasive procedure requiring repeated drainage of fluid from the abdomen using a large needle. The Alfapump offers a less burdensome alternative by automatically and continuously removing ascites, thereby reducing the need for frequent paracentesis.
Dr. H.E. Vargas, Professor of Medicine at the Mayo Clinic College of Medicine, emphasized the importance of this approval, stating, "The approval of Alfapump by the FDA opens the door to a breakthrough therapeutic option for patients with ascites... this technology not only provides effective treatment but also has been shown to improve quality of life."
POSEIDON Study Results
The FDA's approval was based on the successful execution of Sequana Medical's pivotal POSEIDON study, which involved 69 patients across 18 centers in the US and Canada. The study demonstrated that Alfapump significantly reduced the need for therapeutic paracentesis and improved patients' quality of life.
Key findings from the POSEIDON study include:
- Primary effectiveness endpoints at six months post-implantation exceeded predefined thresholds with statistical significance.
- Data at 12 months post-implantation showed a strong and durable clinical profile, virtually eliminating the need for therapeutic paracentesis.
- Improved quality of life, as defined by subjective physical health and ascites symptoms.
- At 24 months, the Alfapump virtually eliminated the need for large volume paracentesis, with an overall survival rate of 62%.
Commercial Launch and Market Opportunity
Sequana Medical is preparing for the US commercial launch of the Alfapump system in the second half of 2025. The company will focus its sales efforts on the 90 liver transplant centers that represent the majority of target customers. The company has received FDA Breakthrough Device Designation for the Alfapump system and has applied for New Technology Add-on Payments (NTAP) to facilitate patient access.
The US market for recurrent and refractory ascites due to liver cirrhosis is forecast to grow by an average of 9% per year, from approximately 70,000 patients in 2025 to 130,000 patients by 2032. This growth is primarily driven by the increasing prevalence of NASH/MASH and alcoholic liver disease. The total market opportunity for Alfapump is estimated at over $2 billion in 2025.
Reimbursement and Coding
In addition to existing ICD-10 procedure codes, the American Medical Association has granted six new CPT® III reimbursement codes for procedures related to the Alfapump system, available for use by healthcare professionals and payors since July 1st, 2024. These codes are expected to further facilitate patient access to the device.
Future Outlook
Ian Crosbie, CEO of Sequana Medical, stated, "With a standard of care that has seen minimal change in thousands of years, today marks a huge milestone for the large and growing liver ascites community in the US... The POSEIDON clinical study results demonstrate that the Alfapump can virtually eliminate the need for therapeutic paracentesis and improve patient quality of life."
