Alfapump implant gains FDA premarket approval for recurrent, refractory cirrhotic ascites
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The FDA has granted premarket approval to Sequana Medical’s alfapump implantable device for the treatment of recurrent or refractory ascites due to cirrhosis, according to a company press release.
This approval marks alfapump as the first implantable device approved in the U.S. to continuously evacuate ascitic fluid from the abdomen into the bladder, Sequana Medical noted in the release.
“The approval of alfapump by the FDA opens the door to a breakthrough therapeutic option for patients with ascites,” Hugo E. Vargas, MD, MS, professor of medicine at the Mayo Clinic College of Medicine in Phoenix, Arizona, said in the release. “The introduction of the system will be welcome by patients, families and their care providers as this technology not only provides effective treatment, but also has been shown to improve quality of life.”
The FDA based its decision on data from the multicenter, prospective, single-arm, crossover pivotal POSEIDON study, which assessed the efficacy and safety of the alfapump system in 69 patients with either refractory or recurrent ascites.
According to data presented during The Liver Meeting in November, at 12 months following implantation, the system demonstrated strong, durable outcomes, improved quality of life and ascites symptoms and nearly eliminated the need for therapeutic paracentesis. At 24 months after implantation, the investigators reported that alfapump had dismissed the need for large-volume paracentesis, with an overall survival rate of 62%
“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 U.S.,” Ian Crosbie, CEO of Sequana Medical, said in the release. “Our vision is to transform the lives of these patients. Recurrent or refractory liver ascites is a devastating condition with a terrible impact on the lives of our patients and their caregivers, not only for the painful and burdensome paracentesis procedure itself but also in the weeks leading up to each drainage.”
Sequana Medical noted that it plans to launch its alfapump system in the U.S. during the second half of 2025, a debut it expects will be supported by New Technology Add-on Payments, which would streamline patient access to the system. Additionally, Sequana highlighted that the AMA has recently issued six CPT III reimbursement codes, supplementing the existing ICD-10 codes, for procedures similar to the alfapump system.
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