Implanted by Mark Farber, MD, professor of surgery, and Raghuveer Vallabhaneni, MD, assistant professor of surgery, the new stent system is the first device designed specifically for a new procedure called TransCarotid Artery Revascularization (TCAR). This procedure combines surgical principles of neuroprotection with minimally invasive endovascular techniques to treat blockages in the carotid artery.
"This procedure is the best of both worlds, giving direct surgical access to the carotid artery without the risks of nerve damage of open revascularization. It also decreases the stroke risk when compared to transfemoral carotid stenting. It is a minimally invasive and safer way of revascularizing appropriate patients,” said Vallabhaneni.
The ENROUTE Transcarotid Stent is indicated for use in High Surgical Risk patients and is intended to be used in conjunction with the ENROUTE Transcarotid Neuroprotection System (NPS) during the TCAR procedure. The ENROUTE Transcarotid NPS is a first in class device used to directly access the common carotid artery and initiate high rate temporary blood flow reversal to protect the brain from stroke while delivering and implanting the ENROUTE Transcarotid Stent.
UNC Medical Center is the only site in North Carolina currently enrolling patients in Silk Road Medical's ROADSTER 2 study. The ROADSTER 2 study is a follow-up to the ROADSTER study, which evaluated the TCAR procedure in 141 patients at high risk for complications from surgery with a composite primary endpoint result of 3.5 percent Stroke (S), Death (D), or Myocardial Infarction (MI) through 30 days.
For more information or to be evaluated for the study, please contact the UNC Division of Vascular Surgery at 919-966-3391.