System Designed Specifically for Novel TransCarotid Artery Revascularization (TCAR) Procedure to be Immediately Launched in the United States
SUNNYVALE, Calif., April 13, 2016 /PRNewswire/ -- Silk Road Medical, Inc., a company dedicated to preventing the devastating burden of stroke through surgical innovation, announced that the United States Food and Drug Administration (US FDA) has granted 510(k) clearance for its next generation ENROUTE Transcarotid Neuroprotection System (NPS). The ENROUTE NPS remains the only device specifically designed and indicated for TransCarotid Artery Revascularization (TCAR), 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 NPS allows the physician to directly access the common carotid artery in the neck and initiate high rate temporary blood flow reversal to protect the brain from stroke while delivering and implanting Silk Road's ENROUTE® Transcarotid Stent. In partnership with treating physicians and based on design feedback from over 700 TCAR procedures, the ENROUTE NPS was enhanced and upgraded to provide physicians with an even more dependable and easy-to-use system to treat patients in the safest manner possible. The first TCAR procedures with the new device were recently performed in leading hospitals including the Ronald Reagan UCLA Medical Center (Los Angeles, CA), Beth Israel Deaconess Medical Center (Boston, MA), Heart Hospital of Austin (Austin, TX), Iowa Methodist Medical Center (Des Moines, IA), Sentara Norfolk General Hospital (Norfolk, VA), and University Hospitals Case Medical Center (Cleveland, OH).
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Silk Road Medical Announces FDA 510(k) Clearance and First Patients Treated in the US with the Next Generation ENROUTE® Transcarotid Neuroprotection System
Via: Yahoo! Finance