Recurrent or refractory ascites is a severe condition characterized by the accumulation of fluid in the abdomen. The current standard treatment involves therapeutic paracentesis, an invasive and burdensome procedure that uses a large needle to drain ascites from the abdomen over an extended period. Sequana Medical has announced that it has received Premarket Approval (PMA) from the United States (US) Food and Drug Administration (FDA) to market alfapump® in the US for the treatment of patients with this condition. This major regulatory milestone, achieved earlier than market expectations, makes alfapump® the first active, implantable medical device in the US that automatically and continuously drains ascites from the abdomen into the bladder.
Patient-Centered Research Demonstrates Risk Tolerance
RTI Health Solutions collaborated with Sequana Medical to conduct a study that helped demonstrate patient preference for alfapump® versus paracentesis. The rigorous study design was prediscussed with the FDA and used discrete-choice experiment methodology to elicit the preferences of US patients with recurrent or refractory ascites due to liver cirrhosis for attributes of an implantable pump as a novel treatment. Patients were surveyed for the risk of treatment-related adverse events they would be willing to accept (risk tolerance) to achieve specific improvements in treatment efficacy (desired benefits).
The study results supported the premise that alfapump® is a desirable treatment option for the majority of patients. Data from the matched-cohort analysis together with the positive data from a clinical trial indicated that patients who received the alfapump® implant benefitted from a significantly reduced number of paracentesis procedures and an improved quality of life without an increased risk of death or hospitalization compared with standard of care.
“It’s rewarding to help patients have a voice in the regulatory decision-making process,” said Christine Poulos, Senior Economist and Vice President of Health Preference Assessment at RTI Health Solutions. “We’re excited that these patients will now have access to this innovation that will have such a positive impact on their quality of life.”
About Sequana Medical
Sequana Medical is seeking to provide innovative treatment options for a large and growing patient population with diuretic-resistant fluid overload. Sequana Medical’s proprietary platforms, alfapump® and DSR®, work with the body to treat diuretic-resistant fluid overload and are intended to deliver major clinical and quality of life benefits for patients, while reducing costs for healthcare systems. Sequana Medical is listed on the regulated market of Euronext Brussels (Ticker: SEQUA.BR) and headquartered in Ghent, Belgium. For further information, please visit www.sequanamedical.com.