Sequana Medical announces unconditional IDE approval from U.S. FDA to ...
Sequana Medical's alfapump pivotal study, POSEIDON, for recurrent or refractory ascites due to liver cirrhosis, received FDA IDE approval, enabling a U.S. launch by H1 2022. The study, involving up to 50 patients, aims to reduce therapeutic paracentesis frequency, with CMS's proposed NTAP pathway changes potentially benefiting the alfapump.
Reference News
Sequana Medical announces unconditional IDE approval from U.S. FDA to ...
Sequana Medical's alfapump pivotal study, POSEIDON, for recurrent or refractory ascites due to liver cirrhosis, received FDA IDE approval, enabling a U.S. launch by H1 2022. The study, involving up to 50 patients, aims to reduce therapeutic paracentesis frequency, with CMS's proposed NTAP pathway changes potentially benefiting the alfapump.