Spryte Medical secured FDA IDE approval to launch INSYTE, a pivotal trial evaluating its neuro optical coherence tomography system as an intravascular imaging adjunct during intracranial aneurysm procedures. First patient enrollment is planned for early 2026. The company positions INSYTE as the first FDA-approved clinical study of an intravascular optical imaging platform purpose-built for the neurovasculature, aiming to deliver micron-level visualization of vessel walls and implanted devices during treatment.
The core event is a registrational step for a new imaging category in neurointervention. While intracoronary OCT is well established, an intracranial-specific OCT catheter-console system has not previously advanced to a pivotal U.S. study. The IDE was supported through the FDA’s Total Product Life Cycle Advisory Program, signaling early agency alignment on development plans. The study will be co-led by high-volume cerebrovascular operators in Chicago and Jacksonville, underscoring a focus on real-world, device-intensive aneurysm workflows where imaging may influence coil placement, stent/flow diverter apposition, and post-deployment assessment.
Strategically, this is an expansion play into an imaging gap that angiography and flat-panel CT have not fully addressed. Spryte is betting that higher-fidelity intraluminal views can reduce uncertainty in device deployment and healing assessment, potentially lowering retreatment rates or thromboembolic complications tied to malapposition—outcomes that could justify added procedural steps and cost. The TAP pathway suggests Spryte and FDA have discussed what constitutes clinically meaningful benefit for an adjunctive imaging device in neuro—likely emphasizing procedural decision changes, device optimization rates, and periprocedural safety—rather than long-horizon clinical endpoints. If successful, the platform could also become a trial-enabling tool for aneurysm device makers, creating a dual revenue and data strategy around imaging-guided development and post-market surveillance.
For sites, the impact is operational. Adopting intravascular neuro OCT introduces a new catheter and console into crowded angio suites, with implications for inventory, staff training, sterile workflow, and heparin/antiplatelet management. Intracranial catheter manipulation carries distinct risks compared with coronaries, including vasospasm, dissection, and thromboembolism; the pivotal study’s safety profile will heavily influence credentialing committees and IRBs. Sponsors and device manufacturers could benefit if the technology enables more objective deployment criteria, standardized core lab reads, and imaging-derived endpoints in registrational and post-approval studies of flow diverters, intracranial devices, and stent-assisted coiling. CROs and imaging core labs will see demand for neuro-specific OCT expertise, DICOM workflows, and adjudication standards that do not yet exist at scale in this space. Regulators are likely to use INSYTE to define expectations for this device class, including labeling limited to aneurysm treatment guidance, operator training requirements, and post-market data collection.
What to watch next is how Spryte frames INSYTE’s endpoints and comparator. The credibility of a new guidance modality will hinge on measurable changes in intra-procedural decisions, reduced device malapposition, and a clean peri-procedural adverse event profile, not just image quality claims. Enrollment pace across diverse aneurysm anatomies and device types will matter for generalizability. Positive results would set up a de novo or PMA pathway and a narrow initial indication; broader adoption will depend on clear workflow integration, catheter compatibility with neuro microcatheters, and evidence that OCT guidance offsets time and cost with fewer complications or reinterventions. If the signal is equivocal—or safety fragile—sites will remain with angiography alone, and neuro OCT may be relegated to niche use or research settings.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
