Galaxy Therapeutics’ SEAL Embolization System Gains CE Mark

August 4, 2026—Galaxy Therapeutics, a company focused on the treatment of intracranial aneurysms, announced it has received CE Mark approval for the company’s saccular endovascular aneurysm lattice (SEAL) device.

The company noted that approval under the European Medical Device Regulation (EU MDR 2017/745) follows successful assessment by notified body DQS Medizinprodukte GmbH.

Galaxy advised that it is preparing the phased commercial introduction of the SEAL embolization system across selected European markets. Additionally, the company continues to advance global regulatory initiatives, including review of its premarket approval application by the FDA.

According to Galaxy, the SEAL system is designed for the endovascular treatment of ruptured and unruptured wide-neck intracranial aneurysms. The device provides an intrasaccular approach intended to simplify aneurysm treatment while addressing a broad range of complex anatomies.

The company advised that the approval builds upon several years of product development, engineering, manufacturing, and clinical investigation, including Galaxy’s international clinical programs and the pivotal United States SEAL IT trial.

“SEAL was developed to address the challenges physicians face when treating complex intracranial aneurysms,” commented Galaxy’s Chief Medical Officer Michael Alexander, MD, in the company’s press release. “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.”