SUNNYVALE, Calif., July 16, 2014 /PRNewswire/ -- Silk Road Medical, Inc. announced today the completion of enrollment in its pivotal ROADSTER study. The trial was the first of its kind to study the treatment of carotid artery stenosis by placing a stent via direct access to the common carotid artery in the neck in an entirely new minimally invasive procedure. The device under study is the Company's ENROUTE™ Transcarotid Neuroprotection System (NPS) which incorporates proven surgical principles to protect the brain from a stroke during carotid angioplasty and stenting, and features a mechanism to divert dangerous debris away from the brain by temporarily reversing blood flow. Data from the trial will be used to support 510(k) clearance of the ENROUTE Transcarotid NPS as well as PMA approval of the ENROUTE Transcarotid Stent System.
The carotid arteries, located on either side of the neck, are the main conduits for blood flow to the brain. Plaque formation in these arteries can put patients at risk for stroke. Stroke is the nation's third leading cause of death, killing nearly 160,000 Americans every year. Approximately 130,000 Americans are treated for narrowing of the carotid arteries each year.
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