Silk Road Medical Announces Updated Clinical Data on TCAR Presented at the 2016 Society for Vascular Surgery Annual Meeting
Presentations from the ROADSTER Study Highlight the Continued Safety, Efficacy and Durability of TransCarotid Artery Revascularization
SUNNYVALE, Calif., June 15, 2016 /PRNewswire/ — Silk Road Medical, Inc., a company dedicated to preventing the devastating burden of stroke through surgical innovation, announced that the 2016 Vascular Annual Meeting of the Society for Vascular Surgery (SVS) held June 8-11 in National Harbor, MD featured six presentations on the company’s ENROUTE® Transcarotid Neuroprotection and Stent System, the first and only products specifically designed and indicated for TransCarotid Artery Revascularization (TCAR).
Christopher Kwolek, MD, Director of the Vascular and Endovascular training program at Massachusetts General Hospital, Chief of Vascular Surgery at Newton Wellesley Hospital, and National Co-Principal Investigator for the ROADSTER Trial, presented “TransCarotid Artery Revascularization with High-Rate Flow Reversal Embolic Protection Demonstrates Improved Stroke and Death Rate Following FDA Premarket Clearance.” Dr. Kwolek presented a 30 day all stroke rate of 1.3% from the Continued Access cohort of patients from the ROADSTER trial, which consisted of an additional 78 high surgical risk patients enrolled beyond the Pivotal cohort of 141 patients while the Pre Market Clearance Application was under review by the Food & Drug Administration (FDA). This compares to a 30 day all stroke rate of 1.4% in the Pivotal cohort, for a combined rate of 1.4% in 219 patients. The 30 day stroke and death rates were 2.8%, 1.3% and 2.3% in the Pivotal, Continued Access, and combined cohorts, respectively. Dr. Kwolek commented that “the combined outcomes in high surgical risk patients are remarkably better than high surgical risk patients treated with conventional carotid endarterectomy (CEA).”
Ignacio Leal, MD, PhD, of Complejo Hospitalario de Toledo in Spain, whose site was the leading enroller in the ROADSTER study, presented “1-Year Follow-up After Transcarotid Artery Revascularization (TCAR) with Enroute Transcarotid Neuroprotection System.” Dr. Leal presented a cohort of 50 consecutive patients, including patients enrolled before and within the ROADSTER trial, and reported no strokes or deaths at 30 days with a 12 month stent patency and stroke free survival rate of 100%. Dr. Leal concluded that “TCAR can be done with a high rate of technical success, an extremely low rate of major adverse events, and excellent 1-year stroke-free survival and stent patency.”
Ann Kim, MD, of University Hospitals Case Medical Center presented a poster titled “Temporary Reversal of Blood Flow During Trans-Carotid Revascularization (TCAR) Does Not Change Brain Electrical Activity” on behalf of her colleagues at Case Medical Center, University of California Los Angeles School of Medicine, and State University of New York at Buffalo. Dr. Kim reported that 28 patients enrolled in the ROADSTER trial underwent electroencephalogram (EEG) monitoring during TCAR with nine patients having bilateral carotid artery disease including four of nine with contralateral occlusion. No EEG or somatosensory evoked potentials (SSEP) changes or adverse events occurred during the implementation of the ENROUTE NPS device in all patients. Furthermore, none of the patients exhibited changes in their pre- and post-intervention neurologic physical exam or their NIH stroke scale (NIHSS). Dr. Kim concluded “Reversal of flow did not elicit any change in brain electrical activity, even in patients with bilateral carotid disease. This finding, coupled with the unchanged post-operative neurologic exam, suggests that temporary reversal of flow is safe. Carotid stenting performed with carotid artery reversal of blood flow can mitigate carotid embolization without causing brain ischemia.”
Vikram Kashyap, MD, Professor and Chief, Division of Vascular Surgery, University Hospitals Case Medical Center, Cleveland, Ohio and Co-Principal National Investigator for the ongoing ROADSTER 2 study, led an SVS/ESVS (European Society of Vascular Surgery) joint debate session titled “During Carotid Artery Stenting, Retrograde Flow is better than Filter-based Embolic Protection Devices for the Prevention of Embolic Stroke.” In his presentation Dr. Kashyap commented that “the very nature of TCAR and its direct carotid approach significantly reduces the risk of stroke, since it does not require embolegenic steps like traversing the aortic arch and the carotid lesion with wires and catheters before implementing neuroprotection. It is simply a more logical approach.”
TCAR with the ENROUTE system was also featured in a Vascular Live presentation titled “TransCarotid Artery Revascularization (TCAR): The Way Forward in Treating Carotid Artery Disease and Stroke Prevention,” featuring Dr. Kashyap, Raghu Motaganahalli, MD, Associate Professor, Indiana University, Indianapolis, Indiana, and Peter Schneider, MD, Chief, Division of Vascular Therapy at Kaiser Foundation Hospital in Honolulu, Hawaii and Co-Principal National Investigator of the ongoing ROADSTER 2 post approval study. During the session Dr. Schneider commented that “ROADSTER 2 is enrolling faster than we anticipated in a broad group of centers including many sites where TCAR has just recently been adopted. There is a high level of enthusiasm for the procedure and this experience will build upon the compelling evidence base from ROADSTER 1.” Dr. Schneider and Dr. Kashyap also led a pre-course education session titled “How to Make Carotid Stenting Competitive with CEA” that featured TCAR and the ENROUTE System.
Silk Road Medical’s Chief Medical Officer Sumaira Macdonald, MD, PhD, commented that “the robust evidence base continues to build for TCAR as a compelling alternative to both carotid endarterectomy and transfemoral carotid artery stenting. With such low peri-procedural stroke rates and the benefit of a less invasive approach, TCAR has the clear potential to be standard of care in the treatment of carotid artery disease.”
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
TCAR is 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. 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.