www.fdanews.com/articles/209992-sequana-medical-posts-promising-data-on-alfapump-device
Sequana Medical Posts Promising Data on Alfapump Device
October 31, 2022
Sequana Medical said that its alfapump, a subcutaneously implanted wirelessly charged pump, showed positive results in patients with recurrent or drug-resistant ascites (excess abdominal fluid) due to liver cirrhosis.
The pump is designed to continually move the excess fluid from the abdominal cavity to the bladder. Most of the 26 patients who completed the study no longer needed the removal of liquid using a needle and syringe.
The company plans on submitting a premarket approval application to the FDA in the second half of 2023.