Galaxy Therapeutics Submits Final Module of PMA for SEAL™ Device
Galaxy Therapeutics has submitted the final module of its Premarket Approval (PMA) application for the SEAL™ device to the U.S. FDA. The submission is based on data from the SEAL IT IDE trial, specifically focusing on wide-neck bifurcation aneurysms, and includes data from 163 patients enrolled at major U.S. neurointerventional centers.
MILPITAS, Calif., April 27, 2026 /PRNewswire/ — Galaxy Therapeutics, a privately held, clinical-stage medical device company focused on treating brain aneurysms, today announced the submission of its final module of its Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for the SEAL™ device for the treatment of wide-neck bifurcation aneurysms (WNBA).
This Modular PMA submission is supported by data from the WNBA cohort of the SEAL IT IDE trial, which enrolled 163 patients across leading U.S. neurointerventional centers. The submission includes the WNBA cohort only. The study was designed to evaluate the SEAL device in a real-world patient population, including a broad range of aneurysm sizes and anatomical complexities.