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ENROUTE Transcarotid Neuroprotection System is intended to provide transcarotid vascular access, introduction of diagnostic agents and therapeutic devices, and embolic protection during carotid artery angioplasty and stenting procedures for patients diagnosed with carotid artery stenosis and who have the appropriate anatomy described below:

• Adequate femoral venous access
• Common carotid artery reference diameter of at least 6 mm.
• Carotid bifurcation is a minimum of 5 cm above the clavicle as measured by duplex Doppler ultrasound (DUS) or computerized axial tomography (CT) angiography or magnetic resonance (MR) angiography

Silk Road Medical, Inc. is the manufacturer of a single use device intended to provide embolic protection during carotid artery angioplasty and stenting procedures. The ENROUTE Transcarotid NPS is designed to transport emboli away from the carotid artery circulation by reversing blood flow at the treatment site prior to crossing a lesion in the carotid artery and during lesion manipulation. It has an in-line filter used to capture and contain embolic material liberated during the procedure.

The ENROUTE Transcarotid NPS consist of three primary components: the ENROUTE Transcarotid Arterial Sheath (Model #1016), the ENROUTE Venous Return Sheath (Model #1026), and the ENROUTE Flow Controller (Model #2031). When assembled, the ENROUTE Transcarotid NPS creates an Arteriovenous Shunt. The Transcarotid Arterial Sheath is placed in the carotid artery below the carotid bifurcation. The Venous Return Sheath is placed into the femoral vein. The Arterial and Venous Sheaths are connected by the Flow Controller, thereby completing the Arteriovenous Shunt. When the carotid artery is occluded just proximal to the Transcarotid Arterial Sheath insertion site, the arterial/venous pressure gradient diverts or reverses the internal carotid artery (ICA) and external carotid artery (ECA) blood flow thereby directing the blood from the cerebral arteries through the Transcarotid Arterial Sheath, through the Flow Controller, and out through the through the Venous Return Sheath into the venous circulation. The ENROUTE Transcarotid NPS is an ethylene oxide sterilized, non-pyrogenic, single-use prescription device.

The associated accessory for use with the ENROUTE Transcarotid NPS is an FDA cleared 0.038" quidewire (K890959). The quidewire is used to facilitate the insertion of the Transcarotid Arterial Sheath into the common carotid artery (CCA) and the Venous Return Sheath into the femoral vein.

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1. Table of Acceptance Criteria and Reported Device Performance

The document focuses on the ROADSTER study's primary endpoint as the key acceptance criterion for effectiveness.

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