Silk Road Medical's Stent System Snags PMA Approval

Silk Road Medical’s Enroute transcarotid stent system — the first of its kind to be implanted into the carotid artery using a direct common carotid access point — has secured FDA premarket approval, the Sunnyvale, Calif., devicemaker announced Tuesday.

The stent has been indicated for high surgical risk patients and is meant to be used alongside the company’s Enroute transcarotid neuropotection system, which won FDA 510(k) clearance in February.

The NPS system provides access to the common carotid artery to reverse high rate temporary blood flow, protecting the brain from stroke.

Silk Road develops medical devices for the treatment of intra- and extracranial cerebrovascular disease. — Jason Scott