Brief: Pixium Vision Receives Approval To Initiate European PRIMAvera Pivotal Study Of Prima System
20/11/2020 06:34
Nov 20 (Reuters) - PIXIUM VISION SA ALPIX.PA :
* PIXIUM VISION RECEIVES FRENCH REGULATORY AUTHORITY (ANSM)
APPROVAL TO INITIATE EUROPEAN PRIMAVERA PIVOTAL STUDY OF PRIMA
SYSTEM
* PRIMAVERA STUDY EXPECTED TO START BY END OF 2020
* PRIMA SYSTEM WILL BE STUDIED IN 38 PATIENTS IN THIS OPEN
LABEL,
BASELINE-CONTROLLED, NON-RANDOMIZED, MULTI-CENTER, PROSPECTIVE,
SINGLE-ARM CONFIRMATORY TRIAL
* STUDY WILL INCLUDE THREE YEARS OF FOLLOW-UP, WITH
ASSESSMENT OF
PRIMARY ENDPOINTS AT 12 MONTHS AFTER IMPLANTATION
* EXPECTS TO REPORT 36-MONTH DATA OF THIS FEASIBILITY STUDY
BY
MID-2021
Source text for Eikon: ID:nGNX6DldzK
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