Silk Road Medical Announces Updated Clinical Data on TCAR Presented at the 44th Annual VEITH Symposium
Presentations from the ROADSTER 1 and ROADSTER 2 Studies Highlight the Excellent Procedural Outcomes and Long Term Durability of TransCarotid Artery Revascularization
SUNNYVALE, Calif., Dec. 12, 2016 /PRNewswire/ — Silk Road Medical, Inc., a company dedicated to preventing the devastating burden of stroke through surgical innovation, announced that the 44th annual VEITH Symposium held November 15-19, 2016, in New York City featured several 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). Highlights include 1-year data on the pivotal cohort from ROADSTER 1 and the first interim analysis of the 30-day data from the ROADSTER 2 Post Approval Study.
Mahmoud Malas, MD, Director of Endovascular Surgery, Johns Hopkins Bayview Medical Center, and National Co-Principal Investigator for the ROADSTER 1 Long Term Follow-Up Study, presented “Midterm Results of the ROADSTER 1 Pivotal Trial of the Silk Road System for TransCarotid Artery Stent Revascularization (TCAR) In High Risk Patients with Carotid Stenosis.” The objective of the ROADSTER 1 Long Term Follow-Up Study is to evaluate the incidence of ipsilateral stroke through one year for patients treated during the pivotal and continued access phases of the ROADSTER 1 Trial. In this ongoing retrospective review of the 141 patients treated in the pivotal phase, Dr. Malas reported outcomes for 87 patients with long term follow-up (median 1.3 years; range 0.5-2.9 years). In this cohort, one patient presented with an ipsilateral stroke following the periprocedural period for an overall one year ipsilateral stroke rate of 1.1%. Data collection in this cohort continues and will be published upon completion. Dr. Malas concluded that long term outcomes with TCAR are comparable to carotid endarterectomy (CEA) in the standard surgical risk population.
Vikram Kashyap, MD, of University Hospitals Case Medical Center and National Co-Principal Investigator of the ROADSTER 2 Study, presented “Early Results of The ROADSTER 2 Post-Market Registry of TCAR in High Risk Patients with Carotid Stenosis.” The ROADSTER 2 Post-Market Study is evaluating the real world use of the ENROUTE Neuroprotection and Stent Systems in a boarder group of operators with little or no TCAR experience. In this interim analysis of high surgical risk patients treated according to the FDA-approved protocol (n=195), Dr. Kashyap reported that the procedural success rate in ROADSTER 2 defined as acute device and technical success in the absence of stroke, death or myocardial infarction at 30 days is 97.5%. Dr. Kashyap further noted that the stroke and death rate in those patients with 30-day follow-up (n=159) is 1.3% and 1.0% for all patients enrolled thus far. With more than 50% of the enrollment coming from new TCAR operators, the outcomes are on par with ROADSTER 1 which reported the lowest stroke rate in any prospective study of carotid revascularization.
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 1 Trial, presented “New Developments In The Silk Road System For TCAR: Details And Improvements In the ENROUTE System For CAS: How It Works And Achieves Flow Reversal Embolic Protection: Indications, Contraindications And Learning Curve Issues.” Dr. Kwolek highlighted the technical improvements in the next generation ENROUTE Neuroprotection System released earlier in 2016 as well as the procedural advantages of the first and only FDA-approved carotid artery stent system indicated for TCAR. Dr. Kwolek noted that new TCAR operators can achieve CEA-like outcomes with a short learning curve.
Silk Road Medical’s President and Chief Executive Officer, Erica Rogers, commented that “with over 1,200 patients treated with TCAR worldwide, the peri-procedural outcomes in clinical trials and real world registries are clearly better than any carotid revascularization paradigm for the high surgical risk patient. These outcomes coupled with the groundbreaking Medicare reimbursement option for TCAR recently announced by the Society for Vascular Surgery Patient Safety Organization will further the proliferation of TCAR as a new standard of care in carotid revascularization.”
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.
SOURCE Silk Road Medical, Inc.