J&J starts SKYWARD study of carotid IVL system

▤ Summary

J&J has started enrollment in its SKYWARD investigational device exemption clinical program for the Shockwave SkyRunner Carotid intravascular lithotripsy system. The studies will test whether the device can safely modify calcified carotid arteries before stenting in patients at elevated risk from carotid endarterectomy. The program includes two prospective, multicenter, single-arm IDE studies covering transcarotid and transfemoral approaches, with up to 320 subjects across as many as 50 US sites. J&J says the purpose-built platform could expand treatment options for challenging carotid disease and generate the evidence needed for broader physician adoption.

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