Shots:
- 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
PharmaShots, your go-to media platform for customized news ranging across multiple indications. For more information, connect with us at connect@pharmashots.com
