Sequana Medical Receives FDA Approval for Alfapump Device Trial
Sequana Medical announced it has received investigational device exemption (IDE) approval from the FDA to conduct a pivotal study of its Alfapump device for patients with recurrent or refractory ascites due to liver cirrhosis. The Alfapump is a fully implantable pump designed to continuously remove excess abdominal fluid in patients with liver disease.
The POSEIDON study, a single arm, open-label, within-subject, crossover trial, will enroll 60 patients in the U.S. and Canada. Participants will undergo a three-month pre-implant observation period receiving standard of care paracentesis therapy before the Alfapump is implanted. Following a three-month stabilization period, a three-month post-implant observation period will commence.
Primary effectiveness outcomes include the proportion of patients achieving a 50% reduction in the overall average monthly frequency of therapeutic paracentesis and the per-patient ratio of average monthly number of therapeutic paracentesis post-implant versus pre-implant. The primary safety endpoint is the rate of Alfapump related re-interventions adjudicated by the clinical events committee.
Patients will be followed up for up to two years for analysis of secondary outcome measurements, including safety, quality of life, nutritional status, health economics, and overall survival.
Sequana Medical plans to launch the Alfapump in the U.S. in the first half of 2022. The company's CEO, Ian Crosbie, highlighted the importance of this development, especially considering the growing prevalence of cirrhosis due to Non-Alcoholic Steatohepatitis (NASH) and the need for modern and convenient ascites treatment options.