Silk Road Gets FDA’s Premarket Approval for Expanded Indications of its Enroute Stent

Silk Road Medical has received the FDA’s premarket approval of an expanded indication for its Enroute stent that includes patients at risk of adverse events from carotid endarterectomy, the surgical removal of the inner part of the carotid artery.

The stent was previously approved for use only in patients with anatomical or physiological criteria that put them at high risk of complications from more invasive surgical procedures, according to the Sunnyvale, Calif.-based company.

The expanded approval was based on study data that demonstrated the stent’s noninferiority in stroke and death rates relative to carotid endarterectomy procedures.

The Enroute stent system also significantly reduced the risk of cranial nerve injury, the company said.