The FDA approved an expanded indication for a transcarotid stent system to include patients at standard risk for adverse events from carotid endarterectomy, according to a press release from Silk Road Medical.
Previously, the stent system (Enroute) was approved for use only in patients with anatomic or physiological criteria that put them at high risk for complications from more invasive surgical procedures.
“This is the first time in history that a stent-based approach has demonstrated noninferiority in stroke and death rates relative to CEA, with our transcarotid artery revascularization [TCAR] system offering the added benefit of significantly reduced cranial nerve injury risk,” Erica Rogers, president and CEO of Silk Road Medical, said in the release. “This label expansion levels a playing field once dominated by open surgical techniques, allowing an expanded number of patients and physicians access to the benefits of a less invasive treatment option.”
Read More: https://www.healio.com/news/cardiac-vascular-intervention/20220503/fda-expands-indication-to-standard-risk-patients-for-transcarotid-stent-system