Silk Road Medical introduces TransCarotid Artery Revascularization using the ENROUTE® Transcarotid Neuroprotection and Stent System. The TCAR procedure combines direct carotid artery access with robust blood flow reversal during ENROUTE Transcarotid Stent placement to remove micro and macro emboli throughout the intervention for CEA-like neuroprotection in a less invasive, more patient-friendly approach.
TCAR – Procedure Details
A small incision is made just above the collar bone to expose the common carotid artery. A soft, flexible sheath is placed directly into the carotid artery and connected to a system that will reverse the flow of blood away from the brain to protect against fragments of plaque that may come loose during the procedure. The blood is filtered and returned through a second sheath placed in the femoral vein in the patient’s thigh. The Neuroprotection system allows balloon angioplasty and stenting to be performed while blood flow is reversed. After the stent is placed successfully to stabilize the plaque in the carotid artery, flow reversal is turned off and blood flow to the brain resumes in its normal direction.
Silk Road’s TCAR Procedure is designed to protect the brain from most sizes and types of embolic debris when introducing interventional devices into the carotid artery. Small emboli, not large enough to cause a major stroke, can still cause a minor brain infarction and impact cognitive function.1-3 A sensitive imaging technology called Diffusion Weighted -Magnetic Resonance Imaging (DW-MRI) can be used to detect these small brain infarctions.
TCAR is a surgically inspired procedure and is designed to mimic the arterial access and safeguards of surgery. In carotid artery surgery, the arteries are clamped above and below the blockage to block blood flow and prevent plaque from traveling to the brain during treatment. Similarly, the ENROUTE® Transcarotid Neuroprotection System isolates the blockage from forward blood flow during stent placement by actually reversing blood flow away from the brain. Because the flow reversal method does not rely on a distally placed filter to capture emboli before they reach the brain, it collects both small and large debris.
Actual debris captured in filters.
(Click for larger image)
Research studies on other neuroprotection devices have shown that filters placed in the artery beyond the disease (distal filters) may not adequately protect the brain from these micro emboli.4 Distal filters, designed to capture plaque but allow blood to pass through them during the procedure, cannot stop the smallest debris from passing through.
Additionally, the process of placing the filter itself can create microemboli. In some research studies, 75-85% of patients undergoing CAS showed evidence of small brain infarctions post-procedure.5
1 Palombo G et al. AJNR Am J Neuroradiol 2008;29:1340-3
2 Wolf O et al. Eur J Vasc Endovasc Surg 2004;27:167-71.
3 Zhou W et al. J Vasc Surg 2009;50:1224-31
4 PROFI: Bijuklic et al. J Am Coll Cardiol 2012; 59:000–000
5 ICSS: Bonati LH et al. Lancet 2010; DOI:10.1016/S1474-4422(10)70057-0.