Silk Road Medical Announces CE Mark Approval and First Patients Treated with the Next Generation ENROUTE® Transcarotid Neuroprotection System

System Designed Specifically for Novel TransCarotid Artery Revascularization (TCAR) Procedure Intended to Prevent Stroke in Patients with Carotid Artery Disease

Mar 15, 2016, 14:40 ET from Silk Road Medical, Inc.

SUNNYVALE, Calif., March 15, 2016 /PRNewswire/ -- Silk Road Medical, Inc., a company dedicated to preventing the devastating burden of stroke through surgical innovation, announced CE Mark approval 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.  In partnership with treating physicians and based on 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 their patients in the safest manner possible.  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.  The first TCAR procedures with the new ENROUTE NPS were recently performed in leading European hospitals including the Virgen de la Salud Hospital in Toledo, Spain, Klinikum rechts der Isar (Technische Universität München) in Munich, Germany, Augusta Krankenhaus in Dusseldorf Germany, John Paull II Hospital in Krakow, Poland and Gent University Hospital in Gent, Belgium.     

"We have been working to improve the safety profile of carotid revascularization through the development of the TCAR procedure, and this latest design of the ENROUTE NPS for TCAR is state-of-the-art," said Dr. Antonio Orgaz, Chief of Vascular Surgery from Virgen de la Salud Hospital. "We were extremely impressed with the smooth, atraumatic entry of the sheath into the carotid artery and the more ergonomic design of the overall system. It is easy to use and inspires confidence."

The first generation ENROUTE NPS was clinically proven in the ROADSTER clinical trial and the data were published in the November 2015 issue of the Journal of Vascular Surgery (Volume 62) where the authors concluded: "The overall stroke rate of 1.4% is the lowest reported to date for any prospective, multi-center 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.

"Whereas elsewhere in the body we routinely use minimally invasive endovascular techniques to treat vascular disorders, carotid artery disease is one of the last frontiers that is still treated primarily by an invasive surgical approach," said Professor Ralf Kolvenbach, Director, Department of Vascular Surgery and Endovascular Therapy at Augusta Krankenhaus.  "This is because techniques used during carotid surgery are very good at protecting the brain during the procedure.  With the ENROUTE NPS we can leverage surgical principles of neuroprotection like avoiding unprotected maneuvers, maintaining exquisite control of the carotid bifurcation and blood flow, and removing embolic fragments of any size.  But we can now do it in a less invasive manner that mitigates the risks of surgical complications like cranial nerve injury and wound complications while providing the patient with an aesthetic result and a quicker recovery."

About Silk Road Medical
Silk Road Medical, Inc. is a private company located in Sunnyvale, CA, that develops and manufactures less-invasive medical devices intended to improve the treatment of carotid artery disease through proprietary transcarotid therapies.  Detailed information can be found at www.silkroadmed.com.

About TCAR with the ENROUTE Transcarotid Neuroprotection and Stent System
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.

About Stroke and Carotid Artery Disease
Every year, 15 million people worldwide suffer a stroke. Nearly six million die and another five million are left permanently disabled. Stroke is the second leading cause of disability globally.[1]  Ischemic strokes account for 80-90% of strokes and an estimated 20-30% of these are caused by disease in the carotid arteries which carry blood to the brain. If left untreated, these blockages can fragment, flow to the brain, and lead to a potentially disabling stroke, also known as a "brain attack." 

ENROUTE is a registered trademark of Silk Road Medical, Inc.

[1] http://www.world-heart-federation.org/cardiovascular-health/stroke/

 

SOURCE Silk Road Medical, Inc.



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