Galaxy Therapeutics today announced that it has received a CE mark under the European Medical Device Regulation (MDR) for the Seal embolization system following successful assessment by Germany-based notified body DQS Medizinprodukte. The CE mark enables commercialisation of the Seal embolization system across the European Economic Area and recognises compliance with the EU’s rigorous requirements for quality management, safety, performance, and clinical evidence, as noted in a Galaxy press release.
Galaxy says it 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 US Food and Drug Administration (FDA).
“Receiving CE mark represents one of the most significant milestones in Galaxy’s history,” said Sam Zaidat (Mercy Hospital, Toledo, USA), the company’s president and chief executive officer (CEO). “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.”
The Seal embolization system is designed for the endovascular treatment of ruptured and unruptured wide-neck intracranial aneurysms. Developed “by physicians, for physicians”, the device offers a novel intrasaccular approach intended to simplify aneurysm treatment while addressing a broad range of complex anatomies. That is according to Galaxy’s press release from earlier today.
The present approval builds upon several years of product development, engineering, manufacturing, and clinical investigation, including Galaxy’s international clinical programmes and the pivotal US SEAL IT investigational device exemption (IDE) trial—described by the company as one of the fastest-enrolling neurovascular IDE studies conducted in the USA.
“Seal was developed to address the challenges physicians face when treating complex intracranial aneurysms,” stated Michael Alexander (Cedars-Sinai Medical Center, Los Angeles, USA), chief medical officer of Galaxy. “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 (2–19mm) than other current intrasaccular technologies offer. We look forward to supporting its thoughtful adoption and continuing to build the clinical evidence around Seal.”
“Achieving CE certification required exceptional collaboration across every function of the company—from engineering and manufacturing to quality, regulatory and clinical operations,” added Jim Twitchell, Galaxy’s chief operating officer. “This approval demonstrates the maturity of our organisation and establishes the operational foundation needed to support commercial expansion throughout Europe and beyond.”
“This approval is much more than a regulatory milestone—it marks the beginning of a new chapter for Galaxy,” said Sergi López García, global director of commercial, marketing and clinical at Galaxy. “Over the past several years, we have worked closely with physicians worldwide to generate robust clinical evidence while simultaneously preparing the commercial infrastructure required for launch. We are excited to partner with clinicians across Europe to ensure patients gain access to this important new treatment option.”
