ROADSTER 2 Data Publication in Stroke Demonstrates Compelling Patient Outcomes and Strong Safety Profile with TCAR
“The publication of the ROADSTER 2 data in Stroke provides further validation of the work we are doing to improve patient safety and deliver strong clinical outcomes. With more than 600 patients studied by investigators of varying experience, these data demonstrate the broad applicability of TCAR as a tool for stroke prevention,” said
The ROADSTER 2 data show stroke and combined stroke and death rates comparable to CEA in 692 high surgical risk patients enrolled in the FDA analysis population, across 43 sites. Sixty-two percent (62%) of patients enrolled in the study were from physicians new to TCAR. In addition, ROADSTER 2 shows lower rates of acute and persistent cranial nerve injury than is typically observed for patients receiving carotid endarterectomy (CEA), the current standard of care.
“The peer-reviewed publication of these data in Stroke reinforces the effectiveness of TCAR as an optimal treatment option for patients with carotid artery disease and high surgical risk factors,” said Dr.
ROADSTER 2 is a prospective, multi-center study designed to assess the real-world usage of the ENROUTE Transcarotid Stent when used with the ENROUTE Transcarotid Neuroprotection System by physicians of varying experience with the TCAR procedure.
Stroke has an audience of 23,900 neurologists, basic scientists, cardiologists, vascular surgeons, internists, interventionalists, neurosurgeons, nurses, and physiatrists. To read the published study, visit: https://www.ahajournals.org/doi/10.1161/STROKEAHA.120.030550
About TCAR with the ENROUTE Transcarotid Neuroprotection and Stent System
TCAR (TransCarotid Artery Revascularization) is a clinically proven procedure combining surgical principles of neuroprotection with minimally invasive endovascular techniques to treat blockages in the carotid artery at risk of causing a stroke. The ENROUTE Transcarotid Stent 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.
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|Lynn Lewis or Caroline Paul||Michael Fanucchi|
Source: Silk Road Medical