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.
Galaxy Therapeutics says SEAL combines a novel 3D spatial design with soft, dual-layer, platinum and nitinol architecture. There are two configurations to treat aneurysms from 2 to 19 mm, and a lead-in marker band to enable easy placement.
The CE approval for SEAL builds upon several years of product development, engineering, manufacturing and clinical investigation, including Galaxy’s international clinical programs and the pivotal U.S. SEAL IT IDE trial, the company said in a news release. Galaxy has not yet published results from this trial.
“Receiving CE mark represents one of the most significant milestones in Galaxy’s history,” said Sam Zaidat, president and CEO of Galaxy Therapeutics. “This achievement reflects years of dedication from our entire team and validates the strength of the clinical evidence, engineering innovation, and quality systems behind SEAL. Most importantly, it allows us to bring this technology to physicians and patients across Europe who are seeking new treatment options for complex brain aneurysms.”
“SEAL was developed to address the challenges physicians face when treating complex intracranial aneurysms,” said Dr. Michael Alexander, chief medical officer of Galaxy Therapeutics. “CE Mark brings a clinically driven technology to European physicians and expands the treatment options available for patients with ruptured and unruptured wide-neck aneurysms for a wider range of aneurysm sizes (2–19 mm) than other current intrasaccular technologies offer. We look forward to supporting its thoughtful adoption and continuing to build the clinical evidence around SEAL.”
According to Galaxy Therapeutics, the company is now preparing the phased commercial introduction of the SEAL Embolization System across selected European markets while continuing to advance global regulatory initiatives, including review of its Premarket Approval (PMA) application by the U.S.
