Silk Road Medical Announces FDA 510(k) Clearance of the ENROUTE® Transcarotid Neuroprotection System
Novel system to protect against stroke via direct carotid access and robust blood flow reversal initiates a new era in carotid revascularization
SUNNYVALE, Calif., Feb. 10, 2015 /PRNewswire/ — Silk Road Medical, Inc., a pioneer in the development of transcarotid therapies for intra and extracranial vascular diseases, announces 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 ENROUTE technology enables a true hybrid procedure offering the best of both worlds – the critical protection against peri-procedural stroke we’ve achieved with carotid endarterectomy (CEA) with the ability to reduce surgical complications using minimally invasive endovascular techniques (CAS),” said Dr. Manish Mehta, Professor of Surgery at Albany Medical College and an Investigator in the ROADSTER trial. “It is also a quick, efficient procedure which can be performed under local anesthesia with minimal scarring, which is highly beneficial for both the patient and the operator.”
Richard Cambria, MD, Chief of the Division of Vascular and Endovascular Surgery at Massachusetts General Hospital and the National Co-Principal Investigator of the ROADSTER trial along with colleague Christopher Kwolek, MD, commented: “We continue to operate on high surgical risk patients because transfemoral CAS has shown excess peri-procedural stroke risk. With the ENROUTE Transcarotid NPS, we now have CEA-like neuroprotection and a simplified procedure that can fulfill the promise of 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.
“Clearance of the ENROUTE Transcarotid NPS is a result of the dedication of the ROADSTER investigators to their patients, the highly collaborative interaction with our colleagues at the FDA, and the hard work of our employees,” said Ric Ruedy, Executive Vice President for Clinical, Regulatory and Quality.
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. “With clearance of the ENROUTE Transcarotid NPS in hand, we are on the eve of commercialization in the United States. Severe carotid artery stenosis is one of the last frontiers in vascular disease that is still treated primarily by an open surgical approach. We look forward to bringing our less invasive, surgically-inspired ENROUTE Systems to market for vascular specialists and their patients,” said Erica Rogers, Chief Executive Officer.
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 intra- and extra-cranial cerebrovascular disease through proprietary transcarotid therapies. Detailed information about Silk Road Medical can be found at www.silkroadmed.com.
Silk Road and ENROUTE are registered trademarks of Silk Road Medical, Inc.
SOURCE Silk Road Medical, Inc.