Galaxy Therapeutics has secured a CE mark for its saccular endovascular aneurysm lattice (SEAL) embolisation system and is now preparing to commercialise the device across Europe.
The California-based company’s SEAL embolisation system is designed for the endovascular treatment of ruptured and unruptured wide-neck intracranial aneurysms.
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Using an intrasaccular approach, SEAL is designed to self-expand inside the aneurysm sac following delivery with a catheter rather than in a blood vessel to disrupt blood flow and cause clotting. This approach is intended to simplify aneurysm treatment while addressing a broad range of anatomies, Galaxy stated.
The overall aim of SEAL is to improve on existing brain aneurysm treatments such as traditional coiling with the development of a device that offers potential benefits including higher mesh density for faster clotting and broader size options for large or shallow aneurysms.
With a CE mark in hand, Galaxy is now preparing for the phased commercial introduction of SEAL across select European markets.
“SEAL was developed to address the challenges physicians face when treating complex intracranial aneurysms,” said Galaxy’s CMO, Dr Michael Alexander.
“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 than other current intrasaccular technologies offer. We look forward to supporting its thoughtful adoption and continuing to build the clinical evidence around SEAL,” Alexander continued.
Aside from its market activities in Europe, Galaxy is also continuing to work on other global regulatory initiatives, including the review of its premarket approval (PMA) application by the US Food and Drug Administration (FDA). To support the PMA, Galaxy is evaluating SEAL in an investigational device exemption (IDE) trial across 50 US sites. Having completed enrolment in December 2025, the study is evaluating SEAL in 279 patients across three cohorts of enrolees with wide-neck bifurcation aneurysms (WNBA), sidewall aneurysms, or ruptured aneurysms.
Upon completing enrolment for the IDE trial, Galaxy said the subgroups represent a “comprehensive evaluation” of its SEAL device across a broad range of clinical scenarios.
Commenting on the CE mark, Galaxy’s chief operating officer, Jim Twitchell, said: “This approval demonstrates the maturity of our organisation and establishes the operational foundation needed to support commercial expansion throughout Europe and beyond.”
