The approval, granted under the EU Medical Device Regulation by DQS Medizinprodukte GmbH, marks the culmination of years of clinical trials and engineering development. Designed by a team of practicing neurointerventional physicians, the device is intended to handle aneurysm sizes ranging from 2 to 19 millimeters, offering a broader clinical range than many existing intrasaccular alternatives. The company leveraged data from its pivotal U.S. SEAL IT IDE trial to support the European application, positioning the system as a primary tool for complex neurovascular procedures.
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Galaxy Therapeutics Secures European Approval for SEAL Embolization System
Milpitas-based Galaxy Therapeutics has secured CE Mark certification for its SEAL Embolization System, clearing the way for the company to launch its neurovascular device across the European Economic Area. The regulatory milestone validates the company’s intrasaccular technology for treating both ruptured and unruptured wide-neck intracranial aneurysms.
Dr. Sam Zaidat, President and CEO of Galaxy Therapeutics, described the certification as a pivotal moment for the firm’s international growth. With the European regulatory hurdle cleared, the company is now initiating a phased commercial rollout across selected markets. Beyond the European launch, Galaxy remains focused on domestic progress, with a Premarket Approval application currently under review by the U.S. Food and Drug Administration.
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