Neurovascular first-in-human is a hospital procedure study with a stroke or aneurysm case mix, not a Phase 1 unit problem. When founders ask where to go outside the US, they usually mean “where can I get ten clean cases without waiting a year for an IDE.” That is a fair question. The unfair version is picking a country first and hoping the operators exist.
What the site has to already do
The lab must already treat the target lesion at volume. A center that does occasional coiling is not a stroke-thrombectomy FIH site. You need documented case mix, 24-hour coverage if the indication is acute, and imaging that can be reconstructed later — DSA, CT, MR — under a protocol, not “whatever the night tech ran.”
You also need a neuro IR or dual-trained operator who will tell you when the device should not go in. Early feasibility in this category fails when the first cases are the wrong anatomy and nobody recorded why.
OUS options that are actually used
Australia and selected European centers if the protocol is already written for an English or EU ethics workflow and you need FDA-facing documentation more than enrollment speed.
Colombia and other high-volume LATAM neurovascular programs when the constraint is case mix and cost, and you are willing to design INVIMA or the local authority, the CEI, and investigational import as one calendar. Stroke and aneurysm volume in large public and private systems is the asset. The risk is treating that volume as if it were an IDE site on day one without locking imaging and device accountability.
Avoid any destination whose pitch is regulatory speed and whose case list cannot show the lesion you need. A fast ethics letter on the wrong anatomy is not a first-in-human. It is a delay with radiation.
Design the study so FDA can use it
OUS neurovascular data can support a later IDE conversation only if inclusion, imaging, and device deficiencies were defined for that use. Write the protocol once. Then pick the two labs that can run it. Country, importer of record, and ethics are how you open those labs — they are not the scientific question.
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