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FDA 510(k) Clearance and First Patients Treated in US With ENROUTE Transcarotid Neuroprotection System


FDA 510(k) Clearance and First Patients Treated in US With ENROUTE Transcarotid Neuroprotection System


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).     

"The best prospect for reducing the peri-procedural risk of stroke during carotid revascularization has been the TCAR procedure, and the technical advancements of the new ENROUTE NPS provide us with even more confidence to safely treat patients in a minimally invasive manner," said Dr. Wesley Moore, Professor and Chief (Emeritus), Division of Vascular Surgery at Ronald Reagan UCLA Medical Center, who performed the first case in the US alongside his colleague Dr. Brian DeRubertis. 

The first generation ENROUTE NPS was FDA 510(k) cleared in early 2015 based on the outstanding results in the pivotal ROADSTER clinical trial.  Study data were published in the Journal of Vascular Surgery (Volume 62) and the authors concluded: "The overall stroke rate of 1.4% is the lowest reported to date for any prospective, multicenter clinical trial of CAS [carotid angioplasty and stenting]."  The next generation ENROUTE NPS was designed with the same flow rate specifications to maintain the excellent neuroprotection seen in the ROADSTER trial.

The new ENROUTE NPS will be immediately launched in the US commercially including in the ongoing ROADSTER 2 post-approval study, a multi-center study designed to assess TCAR in the real world treatment of patients at risk for stroke due to carotid artery disease.  The prospective study will include a minimum of 600 patients at up to 100 sites.  "Our experience suggests that the new ENROUTE NPS is a major step forward in transcarotid design and engineering," commented Dr. Vikram Kashyap, Chief of Vascular and Endovascular Surgery, University Hospitals Case Medical Center, Cleveland, Ohio and Co-National Principal Investigator of the ROADSTER 2 study. "The ROADSTER 2 study will further build the clinical evidence base for the new ENROUTE NPS and the incredibly promising TCAR procedure."

"We have built and trained a world class field organization and achieved significant commercial momentum in a limited market release of our TCAR products," stated Erica Rogers, President and CEO, Silk Road Medical.  "The arrival of the next generation ENROUTE NPS will allow us to commence full commercial launch and continue our quest towards establishing TCAR as the standard of care in preventing strokes from severe carotid artery disease."  

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