Technology | June 01, 2015

Silk Road Medical Announces FDA 510(k) Clearance of the Enroute Transcarotid Neuroprotection System

Novel system protects against stroke via direct carotid access and robust blood flow

June 1, 2015 — Silk Road Medical Inc. announced the company received U.S. Food & Drug Administration (FDA) 510(k) clearance for its Enroute transcarotid neuroprotection system (NPS). The Enroute transcarotid NPS is 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 periprocedural stroke we've achieved with carotid endarterectomy (CEA) with the ability to reduce surgical complications using minimally invasive endovascular techniques (CAS)," said Manish Mehta, M.D., 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, M.D., commented: "We continue to operate on high surgical risk patients because transfemoral CAS has shown excess periprocedural 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 percent 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, which is an optimized stent delivery system designed for use with the Enroute transcarotid NPS.

For more information: www.silkroadmed.com

Related Content

Boston Scientific Closes Claret Medical Acquisition, Announces Positive Reimbursement Decision
News | Embolic Protection Devices | August 03, 2018
Boston Scientific Corp. announced it has recently closed its acquisition of Claret Medical Inc., a privately-held...
Claret's FDA-cleared Sentinel Cerebral Embolic Protection System for TAVR will expand Boston Scientific's structural heart portfolio. It collects emboli knocked loose that would otherwise lodge in the brain and potentially cause a stroke.

Claret's FDA-cleared Sentinel Cerebral Embolic Protection System for TAVR will expand Boston Scientific's structural heart portfolio. It collects emboli knocked loose that would otherwise lodge in the brain and potentially cause a stroke. 

News | Embolic Protection Devices | July 20, 2018
July 20, 2018 — Boston Scientific Corp.
The Emboliner Embolic Protection Catheteris designed to capture debris released from the valve and vessel walls during transcatheter aortic valve replacement (TAVR) procedures.

The Emboliner Embolic Protection Catheter is designed to capture debris released from the valve and vessel walls during transcatheter aortic valve replacement (TAVR) procedures. It allows for the passage of other catheters during TAVR procedures. 

News | Embolic Protection Devices | June 07, 2018
June 7, 2018 — The first clinical cases have been completed where the Emboliner...
Sentinel Cerebral Protection System Reduces TAVR Strokes More Than 60 Percent
News | Embolic Protection Devices | May 08, 2018
May 8, 2018 — One-year results from the Sentinel Cerebral Protection System show it can reduce the incidence of...
Emboline Inc. Completes Funding for TAVR Embolic Protection Trial
News | Embolic Protection Devices | April 20, 2018
Emerging medical device company Emboline Inc. announced it has completed a Series B funding round totaling over $10...
Sentinel Cerebral Protection System Reaches 50-Center Adoption Milestone in U.S.
News | Embolic Protection Devices | February 19, 2018
Claret Medical announced that since U.S. Food and Drug Administration (FDA) clearance in June 2017, its Sentinel...
The Boston Scientific FilterWire EZ embolic protec filter system.

The Boston Scientific FilterWire EZ embolic protection system.

News | Embolic Protection Devices | October 31, 2017
October 31, 2017 — The VAMPIRE 3 study evaluated if the selective use of distal filter protection might decrease the
Claret Medical Closes $14.5 Million in Series C Financing for Sentinel Cerebral Protection System
News | Embolic Protection Devices | October 23, 2017
October 23, 2017 — Claret Medical announced that it has closed on a Series C financing of $14.5 million led by Lights
Sentinel Cerebral Protection System Significantly Reduces Stroke and Mortality in TAVR
News | Embolic Protection Devices | September 18, 2017
September 18, 2017 – Claret Medical announced publication of a new study in the...
Protembis Announces Successful First-in-Human Use of  ProtEmbo Cerebral Protection System in European Trial
News | Embolic Protection Devices | September 07, 2017
Protembis GmbH announced the first clinical applications of its ProtEmbo Cerebral Protection System to complement a...
Overlay Init