The CE mark follows successful assessment by Notified Body DQS Medizinprodukte GmbH.
SEAL (which stands for Saccular Endovascular Aneurysm Lattice Embolization System) is meant for the endovascular treatment of ruptured and unruptured wide-neck intracranial aneurysms.
Intrasaccular flow-disruptor devices, such as SEAL, have emerged in recent years as neurointerventional tools that overcome drawbacks of more established endovascular techniques, including balloon-assisted coiling, stent-assisted coiling, and flow diversion, according to a 2024 study published in the Journal of Clinical Medicine.