FDA approves expanded indications for TCAR’s Enroute stent

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The Food and Drug Administration (FDA) approved expanded indications for the Enroute stent system—part of the transcarotid artery revascularization (TCAR) procedure—to include patients at standard risk for adverse events from carotid endarterectomy (CEA), Silk Road Medical announced today. Previously, the stent was approved for use only in patients with anatomic or physiological criteria that put them at high risk of complications from more invasive surgical procedures.

Silk Road submitted a premarket approval supplement, which included data extracted from the Vascular Quality Initiative (VQI) representing real-world outcomes in 20,264 patients considered at standard surgical risk, the company said. Those data demonstrated that use of the TCAR system is statistically non-inferior in stroke and death outcomes to CEA, while showing a ninefold reduction in cranial nerve injury (CNI) (2.7% vs 0.3%, p<0.001), the press release added.

“Pairing the right patient with the right treatment results in significantly improved physician and patient experiences and outcomes. I speak for the vascular community in welcoming this label expansion for TCAR, and recognizing this as a vital advancement in the treatment paradigm for patients at risk of stroke,” said Marc L. Schermerhorn, MD, chief in the division of vascular and endovascular surgery at Beth Israel Deaconess Medical Center in Boston.

“The decision regarding which patients to treat with TCAR is no longer restricted to patients at high surgical risk, providing a greater opportunity for the care team to pursue the less invasive approach for a broader set of their patients.”

The Enroute stent is intended to be used in conjunction with TCAR’s Enroute neuroprotection system. The system combines surgical principles of neuroprotection with minimally invasive endovascular techniques to treat blockages in the carotid artery at risk of causing a stroke.

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