The results of a clinical trial investigating the effectiveness and safety of Sequana Medical’s implantable pump that controls ascites will be unveiled this week at the European Association for the Study of the Liver (EASL) Annual Congress 2023.
Principal investigator Dr Florence Wong will present the results at the congress, which is taking place from 21 to 24 June.
The POSEIDON study (NCT03973866) conducted by Sequana Medical is investigating the company’s alfapump system. The device is a fully implantable pump that collects ascites as it forms and sends it to the bladder for elimination through urination.
Ascites is a condition that causes fluid to collect in the abdomen and is a common sign of liver damage.
The alfapump system received CE mark approval in 2011 and is included in the EASL’s clinical practice guidelines for decompensated cirrhosis. The UK’s National Institute for Health and Care Excellence (Nice) also has it on its interventional procedure guidance for cirrhosis-induced refractory ascites.
Sequana Medical says it intends data from the POSEIDON study to support US Food and Drug Administration (FDA). The Belgium-based company plans to file a pre-market approval (PMA) application soon with the FDA based on positive topline data at six months post-implantation.
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The POSEIDON trial is a multi-centre, prospective, single-arm, crossover pivotal study. The study saw 70 pivotal cohort patients (up to 45 additional roll-ins) with refractory or recurrent ascites implanted with the device after a three-month pre-implant observation phase (with standard-of-care therapy). An analysis of follow-ups after two years with the implant constitutes the data.
The number of draining procedures required pre-implant and post-implant and surgical reintervention due to adverse events make up the primary outcomes. The trial took place across approximately 20 centres in the US and Canada.