FDA Approval of Alfapump Marks a Breakthrough in Treatment for Recurrent Ascites
Sequana Medical NV has achieved a groundbreaking milestone with the US FDA approval of its Alfapump system for the treatment of recurrent or refractory ascites caused by liver cirrhosis.
This approval positions the Alfapump as the first active implantable medical device for this condition in the United States, offering a transformative solution for patients battling this debilitating disease.
A Breakthrough in Patient Care
The significance of this FDA approval was underscored by a professor from the Mayo Clinic, who described it as a breakthrough therapeutic option for ascites patients.
The professor highlighted how the Alfapump system not only provides effective treatment but also significantly enhances patients’ quality of life. Recurrent ascites, a condition characterised by fluid accumulation in the abdomen due to liver dysfunction, has long required frequent and invasive procedures such as therapeutic paracentesis.
However, the Alfapump system eliminates this need by automatically and continuously transferring fluid from the abdomen to the bladder for natural excretion.
Transforming Lives
Sequana Medical’s CEO celebrated this achievement as a monumental step forward for the liver ascites community.
The CEO emphasised the company’s mission to empower patients to take back their lives with a solution designed to improve autonomy and well-being.
Furthermore, early evidence from the POSEIDON study supports these claims, demonstrating significant improvements in patients’ quality of life following the implementation of the Alfapump system.
Commercial Plans and Market Opportunity
With over 1,000 successful implants worldwide, the Alfapump system is set to make its US debut in the second half of 2025. Sequana Medical plans to target liver transplant centers, utilising a specialised sales force to ensure an effective launch.
The market opportunity for the Alfapump system is expected to exceed $2 billion (approx £1.6 billion) by 2025, fueled by the rising prevalence of liver conditions such as nonalcoholic steatohepatitis (NASH/MASH) and alcoholic liver disease.
Collaborative Efforts and Industry Support
The Chief Commercial Officer expressed enthusiasm for the clinical community’s positive feedback on the Alfapump system, adding that preparations for its commercial launch are well underway.
The company aims to establish the Alfapump as the new standard of care for patients with recurrent ascites.
What’s more, Sequana Medical’s Global Vice President of QM/QA/RA lauded the PMA approval as the result of years of diligent work, thanking the FDA for its collaboration in bringing this innovative device to US patients.
A New Chapter in Medical Innovation
As Sequana Medical prepares for the Alfapump’s US launch, the approval underscores the device’s potential to redefine the management of recurrent ascites.
Combining clinical efficacy, patient-centered design, and groundbreaking technology, the Alfapump represents a monumental step forward in liver disease care.
With its anticipated launch, the company aims to deliver on its promise of transforming lives and setting a new standard of care for patients across the nation.
News Credits: FDA approves Sequana Medical’s Alfapump for ascites treatment
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