FDA approved a PMA for Silk Road Medical Inc.'s Enroute transcarotid stent, the firm announced May 19. It is the first carotid stent introduced and implanted into the carotid artery through direct common carotid access , which enables controlled and quick placement, according to Silk Road. In conjunction with the Enroute transcarotid neuroprotection system, which was 510(k)-cleared earlier this year, the system avoids potential stroke hazards typically associated with carotid stents via a procedure called transcarotid artery revascularization (TCAR), the firm says.(See [A#01150216002].)
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