Galaxy Therapeutics has announced it has successfully completed enrolment in SEAL IT, the company’s US investigational device exemption (IDE) pivotal trial evaluating the Seal device for brain aneurysms. The multicentre, prospective study brought together 50 sites and enrolled 279 patients across three key aneurysm cohorts: wide-neck bifurcation aneurysms (WNBAs), sidewall aneurysms, and ruptured aneurysms.
According to Galaxy, the study’s WNBA subgroup builds upon the prior framework established by the WEB-IT trial and is set to extend the indication for intrasaccular therapies to a broader range of aneurysm sizes. Additionally, the sidewall cohort addresses single-vessel, non-bifurcation aneurysms, while the ruptured arm includes patients treated in the acute phase of subarachnoid haemorrhage. Together, these subgroups represent a comprehensive evaluation of the Seal device across a wide spectrum of clinical scenarios, the company claims.
“Completing enrolment in SEAL IT is a major milestone—not only for Galaxy but for the field of neurointervention,” said Osama Zaidat (Mercy Hospital, Toledo, USA), president and chief executive officer (CEO) of Galaxy. “We designed this study to reflect real-world aneurysm complexity and believe the evidence generated will meaningfully advance the care of these patients.”
“It is impressive that all three arms of the trial progressed so rapidly,” added Galaxy chief medical officer Michael Alexander (Cedars-Sinai Medical Center, Los Angeles, USA). “It’s a testament to our enrolling physicians’ ability to integrate a new device into their practices and the ease of use of the device itself.”
“SEAL IT represents an important step in advancing clinical research for complex aneurysms, such as wide-neck bifurcations,” commented David Altschul (Montefiore Medical Center, New York, USA), principal investigator for the SEAL IT study. “The design of the study reflects a broad, real-world population, and I’m grateful to all participating centres and colleagues.”
“SEAL IT is one of the first prospective US IDE trials to include a ruptured aneurysm cohort, a critical and underrepresented population in device studies,” stated fellow SEAL IT principal investigator Brian Jankowitz (Hackensack Meridian Neuroscience Institute, Edison, USA). “To our knowledge, it is also among the fastest-enrolling aneurysm studies in the USA—a testament to the engagement of investigators across the country.”
Galaxy says it will now focus on data analysis and preparation for premarket submission while also continuing to support its global clinical programmes.
