The Ghent, Belgium-based company’s pump treats these fluid overload conditions that arise due to liver cirrhosis and malignant ascites.
In addition to the milestone implant, Sequana said it received all administrative clearances to begin its U.S. MOJAVE study. This study evaluates its DSR 2.0 fluid overload pump therapy in congestive heart failure patients. The company expects to enroll the first patient imminently, according to a news release.
Sequana plans to submit Alfapump to the FDA for premarket approval later this year. It also has preparations underway for a North American commercial launch through its own specialty salesforce.
“We developed the Alfapump to transform the lives of patients with recurrent and refractory ascites due to liver disease,” said Ian …