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Spryte Medical has completed enrollment in the INSYTE Trial, a key clinical study evaluating its investigational nOCT™ Imaging System for use during endovascular treatment of intracranial aneurysms.
The FDA-approved IDE study enrolled 65 patients across 8 centers in 3 countries and is designed to assess the safety and effectiveness of the company’s neuro intravascular optical coherence tomography technology in generating high-resolution images during aneurysm treatment and follow-up.
“Completing enrollment in the INSYTE Trial is a major achievement for Spryte Medical and reflects years of collaboration among physicians, clinical partners, engineers, and regulatory stakeholders,” said David W. Kolstad, CEO of Spryte Medical. “We are excited to take the next step toward an FDA submission and ultimately bring this technology to neurointerventional teams across the United States.”
With enrollment complete, Spryte will focus on trial completion and preparation for FDA submission. If approved, the nOCT Imaging System could provide neurointerventionalists with real-time visualization of vessel anatomy, device–tissue interactions, and vessel wall pathology to support more precise aneurysm treatment decisions.
