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October 04, 2015 1:25 PM ET


Company Overview of Silk Road Medical Inc.

Company Overview

Silk Road Medical Inc. provides research and development services for neurovascular diseases. The company was founded in 2007 and is based in Sunnyvale, California.

735 North Pastoria Avenue

Sunnyvale, CA 94085

United States

Founded in 2007





Key Executives for Silk Road Medical Inc.

Chief Executive Officer and President
Chief Medical Officer
Chief Technology Officer
Executive Vice President of Corporate Development & Commercialization
Compensation as of Fiscal Year 2015.

Silk Road Medical Inc. Key Developments

Silk Road Medical Appoints Andrew Davis as Executive Vice President of Global Sales

Silk Road Medical Inc. announced the appointment of Andrew (Andy) Davis to the position of Executive Vice President of Global Sales. In this new role, Andy will assemble a sales organization and lead the company's commercialization efforts for the TransCarotid Artery Revascularization (TCAR) procedure with the ENROUTE® Transcarotid Neuroprotection System (NPS) and the ENROUTE® Transcarotid Stent System. Prior to joining Silk Road Medical, Andy was the Vice President of Sales and Marketing at Acelity's Advanced Wound Therapy Group and previously held Vice President of Sales positions for Medtronic's CoreValve, Endovascular, Peripheral and Spinal/Biologics divisions.

FDA Grants Premarket Approval for Silk Road Medical's ENROUTE® Transcarotid Stent System

Silk Road Medical Inc. announced the company has received Premarket Approval (PMA) from the United States Food & Drug Administration (FDA) for the ENROUTE Transcarotid Stent System. The ENROUTE Transcarotid Stent is the first carotid stent that is introduced and implanted into the carotid artery through a direct common carotid access point to enable a safe and more direct approach to carotid artery stenting. The ENROUTE Transcarotid Stent is indicated for use in High Surgical Risk patients and is intended to be used in conjunction with Silk Road Medical's ENROUTE Transcarotid Neuroprotection System (NPS), which recently received 510(k) clearance by the FDA. Together the ENROUTE Transcarotid NPS and Stent System enables a novel hybrid procedure called TransCarotid Artery Revascularization (TCAR), which combines surgical principles of neuroprotection with a less invasive stenting procedure. The ENROUTE Transcarotid NPS is a first in class system 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.

Silk Road Medical Announces FDA 510(k) Clearance of ENROUTE® Transcarotid Neuroprotection System

Silk Road Medical Inc. announced the company has received Food & Drug Administration (FDA) 510(k) clearance for its ENROUTE Transcarotid Neuroprotection System (NPS). The ENROUTE Transcarotid NPS is a first in class system used to directly access the common carotid artery and initiate high rate temporary blood flow reversal to protect the brain from stroke while performing carotid angioplasty and stenting (CAS). The FDA cleared the ENROUTE Transcarotid NPS based in part on the results of the ROADSTER trial, which achieved a 30 day stroke rate of 1.4% in the pivotal cohort, the lowest to date for any prospective trial of CAS. There were no major strokes and there were no strokes in important high risk subgroups, including the elderly (age ¥75), women, and symptomatic patients. Silk Road Medical has also submitted a Premarket Approval (PMA) application for the ENROUTE Transcarotid Stent System (Stent), which is an optimized stent delivery system designed for use with the ENROUTE Transcarotid NPS.

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