Sequana Medical said it has received investigational device exemption approval from the FDA to conduct a pivotal study of its Alfapump device for patients with recurrent or refractory ascites due to liver cirrhosis.

Alfapump is a fully implantable pump designed to continuously remove excess abdominal fluid in patients with liver disease. Zurich-based Sequana has applied to Health Canada for Investigational Testing Authorisation (ITA) as well. The company won CE Mark approval for the device in 2011.

The single arm, open-label, within-subject, crossover POSEIDON study will enroll 60 patients in the U.S. and Canada. Patients will enter into a three-month pre-implant observation period in which they will receive standard of care paracentesis therapy before Alfapump is implanted. Following a three-month stabilization period, a three-month post-implant observation period will begin.

The study’s primary effectiveness outcomes include the proportion of patients with 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 plans to launch Alfapump in the U.S. in the first half of 2022.

“This is good news for patients as the growing prevalence of cirrhosis due to Non-Alcoholic Steatohepatitis (NASH) makes the need for a modern and convenient ascites treatment all the more important,” said Sequana Medical CEO Ian Crosbie in a news release. “We are also encouraged by the recent announcement from CMS in respect of proposed changes to the new technology add-on payment (NTAP) pathway for breakthrough devices, which we believe is a very promising development for the Alfapump.”