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Galaxy has received CE Mark under the EU MDR 2017/745 for its SEAL Embolization System, following assessment by Notified Body DQS Medizinprodukte. Launch expected across selected EU markets, with FDA’s PMA application underway
The SEAL Embolization System is an intrasaccular device for endovascular treatment of ruptured & unruptured wide-neck intracranial aneurysms, supporting aneurysm sizes of 2–19mm with a simplified physician-designed approach
The approval follows years of product development, engineering, manufacturing, and clinical research, incl. international studies and the US SEAL IT IDE trial, one of the fastest-enrolling neurovascular IDE studies in the US
Ref: PRnewswire | Image: Galaxy Therapeutics | Press Release
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