Minneapolis, MN – January 14, 2016 – The carotid arteries supply oxygenated blood to the brain. Every year, more than 300,000 people in the United States are diagnosed with blockages, or plaques, in their carotid artery. When these arteries become blocked due to plaque build-up, an individual is at high risk for a stroke if the plaque ruptures and flows to the brain. Many individuals can manage carotid artery disease with medications and lifestyle changes. However, many may require carotid artery revascularization surgery to repair the blockage in the artery. Carotid endarterectomy has been the gold standard of treatment with carotid stenting reserved for those who are high risk for open surgery. While largely effective in some patients, carotid stenting from the transfemoral route has been found to carry a higher risk of stroke, with a significant amount of this risk felt to be related to the approach.
The FDA recently approved a new Transcarotid Artery Revascularization (TCAR) procedure that utilizes the ENROUTE® Transcarotid Neuroprotection and Stent System from Silk Road Medical. The TCAR procedure offers patients a potentially safer method of carotid stenting through a small cut down at the base of the neck and direct carotid artery access along with neuro-protective flow reversal during delivery of the stent. The Minneapolis Heart Institute Foundation® (MHIF) was selected as the only center in the four state area to participate in the ROADSTER 2 Study. Jessica Titus, MD, and Timothy Sullivan, MD, vascular surgeons at the Minneapolis Heart Institute® at Abbott Northwestern Hospital, will serve as Principal Investigator and Co-Investigator, respectively, for the trial. "We are excited to be able to bring this carotid artery revascularization option to our patients. It combines the advantages of a minimally invasive approach for high risk patients with a lower stroke risk than the standard method for carotid stent placement." said Dr. Titus.
The ENROUTE Transcarotid Neuroprotection System utilizes robust flow reversal during transcarotid stent placement to remove micro and macro emboli throughout the intervention. Erica Rogers, CEO of Silk Road Medical notes, "We selected the staff and researchers at MHIF as a key trial partner because they have the vascular surgery and research expertise we need to participate in this important study and provide this less invasive and more efficient TCAR procedure for their patients presenting with carotid artery disease." The first registry trial participant at MHIF is scheduled for first quarter 2016. In total, the ROADSTER2 study will assess the real world treatment of individuals at risk for stroke due to carotid artery disease with the ENROUTE® Transcarotid Neuroprotection (NPS) and Stent System with a minimum of 600 participants around the country.
About the Minneapolis Heart Institute Foundation
The Minneapolis Heart Institute Foundation (MHIF) strives to create a world without heart and vascular disease. To achieve this bold vision, it is dedicated to improving the cardiovascular health of individuals and communities through innovative research and education.
- Scientific Innovation and Research — MHIF is a recognized research leader in the broadest range of cardiovascular medicine and population health initiatives. Each year MHIF leads more than 175 active research projects and publishes more than 120 peer-reviewed studies. Cardiologists, hospitals and communities around the world adopt MHIF protocols to save lives, improve care and create healthier living opportunities.
- Education and Outreach — MHIF provides more than 10,000 hours of education each year putting its research into practice to improve outcomes. And, MHIF leads cutting-edge, transformative population health research to connect, engage, inform and empower individuals and communities to improve their health.
The Minneapolis Heart Institute Foundation's work is funded by generous donors and sponsors and supports research initiatives of Minneapolis Heart Institute® at Abbott Northwestern Hospital.
Minneapolis Heart Institute® physicians provide care for patients at Abbott Northwestern Hospital in Minneapolis and at 38 community sites across Minnesota and western Wisconsin.
About TCAR with the ENROUTE Transcarotid Neuroprotection and Stent System
The ENROUTE Transcarotid Stent is indicated for use in High Surgical Risk patients and 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.
ENROUTE is a registered trademark of Silk Road Medical, Inc.
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 http://www.silkroadmed.com.