Brief: Sequana Medical Announces IDE Approval From U.S. FDA

Sequana Medical NV

04/06/2019 06:07

June 4 (Reuters) - SEQUANA MEDICAL NV  SEQUA.BR :
    * SEQUANA MEDICAL ANNOUNCES UNCONDITIONAL IDE APPROVAL FROM
U.S.
FDA TO START ALFAPUMP PIVOTAL STUDY (POSEIDON)
    * ALFAPUMP PIVOTAL STUDY FOR TREATMENT OF RECURRENT OR
REFRACTORY
ASCITES DUE TO LIVER CIRRHOSIS
    * OPTIMISED CLINICAL TRIAL DESIGN OF UP TO 50 PATIENTS
IMPLANTED
WITH ALFAPUMP IN STUDY COHORT AND SHORTER FOLLOW-UP TIME FOR
PRIMARY ENDPOINT ANALYSIS
    * PLANNED U.S. LAUNCH OF ALFAPUMP MOVED FORWARD TO H1 2022
    * PROPOSED RULE OF CENTERS FOR MEDICARE AND MEDICAID
SERVICES
(CMS) ON PAYMENT SYSTEM FOR BREAKTHROUGH DEVICES IS A POSITIVE
DEVELOPMENT FOR ALFAPUMP

Source text for Eikon:  ID:nGNE8fFxmm 
Further company coverage:  SEQUA.BR 

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