Positive results from POSEIDON, Sequana Medical’s North American pivotal study of its implantable alfapump device in patients with recurrent and refractory ascites (RRA), should pave the way for the company to file a US premarket approval application (PMA) with the FDA in H223. The study convincingly met the primary efficacy endpoints and, given that no unanticipated adverse device effects (UADE) were observed, we believe that these results should de-risk the likelihood of US market approval and ....
03 Nov 2022
Sequana Medical - POSEIDON results de-risk alfapump programme
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Sequana Medical - POSEIDON results de-risk alfapump programme
Positive results from POSEIDON, Sequana Medical’s North American pivotal study of its implantable alfapump device in patients with recurrent and refractory ascites (RRA), should pave the way for the company to file a US premarket approval application (PMA) with the FDA in H223. The study convincingly met the primary efficacy endpoints and, given that no unanticipated adverse device effects (UADE) were observed, we believe that these results should de-risk the likelihood of US market approval and ....