Results Published From TCAR Surveillance Project
December 18, 2019—Silk Road Medical, Inc. announced that positive results from the ongoing TransCarotid Artery Revascularization (TCAR) Surveillance Project comparing TCAR and transfemoral carotid artery stenting (TF-CAS) have been published by Marc L. Schermerhorn, MD, et al in Journal of the American Medical Association (JAMA) (2019;322:2313–2322).
Data From the TCAR Surveillance Project Support Silk Road Medical's Enroute Devices
November 22, 2019—Silk Road Medical, Inc. announced the presentation of real-world data from the ongoing TransCarotid Artery Revascularization (TCAR) Surveillance Project at the VEITHsymposium held November 19–23 in New York, New York.
European Societies Publish Consensus Document on Follow-Up After Revascularization for PAD
November 14, 2019—A consensus document from European societies on the follow-up of patients after revascularization for peripheral artery disease (PAD) was published by Maarit Venermo, MD, et al in the European Journal of Vascular and Endovascular Surgery (2019;58:641–653).
Findings Published From Review and Analysis of RCTs Comparing CEA and CAS
September 26, 2019—Andrew J. Batchelder, MD, Athanasios Saratzis, MD, and A. Ross Naylor, MD, published findings of an overview of primary and secondary analyses from 20 randomized controlled trials (RCTs) comparing carotid artery stenting (CAS) with carotid endarterectomy (CEA). The study is published in European Journal of Vascular and Endovascular Surgery (EJVES; 2019;58:479–493).
Published Early Results From Matched Analysis Show Similar Risks for TCAR and CEA
July 23, 2019 – The Society for Vascular Surgery (SVS) announced the publication of the first report of a matched analysis of transcarotid artery revascularization (TCAR) and carotid endarterectomy (CEA), revealing a similar incidence of stroke and death at 30 days and 1 year.
ROADSTER-2 Demonstrates Positive Patient Outcomes With Silk Road's Enroute TCAR Systems
June 15, 2019—Silk Road Medical, Inc. announced positive final results for the company’s ROADSTER-2 postmarketing study evaluating real-world use of the Enroute neuroprotection and stent systems in transcarotid artery revascularization (TCAR) procedures.
Favorable Outcomes for TCAR Versus CEA Presented at Vascular Annual Meeting
June 13, 2019—Silk Road Medical, Inc. announced real-world data from the ongoing TransCarotid Artery Revascularization (TCAR) Surveillance Project evaluating the treatment of patients with carotid artery disease at risk for stroke.
Age-and-Outcomes Analysis of the VQI Supports TCAR in Elderly Patients
June 12, 2019—Hanaa Dakour-Aridi, MD, revealed findings from a study composed of patients in the Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI) that compared the association between age and outcomes after transcarotid artery revascularization (TCAR), transfemoral carotid artery stenting (TFCAS), and carotid endarterectomy (CEA).
Interim SIBERIA Data Evaluate InspireMD's CGuard EPS MicroNet Carotid Stent
January 24, 2019—InspireMD, Inc. announced that interim findings from the investigator-initiated SIBERIA trial of the company's CGuard embolic prevention system (EPS) were presented at LINC, the Leipzig Interventional Course held January 22–25 in Leipzig Germany.
Thirty-Day Results Published From SCAFFOLD Trial of Mesh-Covered Gore Carotid Stent
December 12, 2018—The 30-day results from the SCAFFOLD trial demonstrated a low rate of a composite of major adverse events (MAEs) including death, stroke, or myocardial infarction after carotid artery stenting (CAS) with the Gore carotid stent (GCS; Gore & Associates) in patients at high risk for carotid endarterectomy (CEA).
UK NICE Seeks Comments on Draft Guideline for Thrombectomy in Stroke Patients
December 5, 2018—NICE, the United Kingdom's National Institute for Health and Care Excellence, announced an updated draft guideline stating that patients with acute ischemic stroke should be treated with thrombectomy and thrombolytic drugs up to 24 hours after the onset of symptoms if there is potential to salvage brain tissue.
Long-Term Data Presented From European Registries of InspireMD's CGuard EPS
November 29, 2018—InspireMD, Inc. announced that updated data on the company's CGuard embolic prevention system (EPS) for the prevention of stroke caused by the treatment of carotid artery disease were presented at the 45th annual VEITHsymposium held November 13–17 in New York, New York.
VQI Study Shows Similar Outcomes for TCAR Versus CEA, With Lower CNI and OR Time
November 20, 2018—Transcarotid artery revascularization (TCAR) showed similar rates of in-hospital stroke and death yet shorter operating room (OR) time and fewer cranial nerve injuries (CNIs) than carotid endarterectomy (CEA) in a study presented at the 2018 VEITHsymposium in New York, New York.
Swedish Study Shows Expedited Carotid Intervention Improves Recurrent Ischemic Event Rate
October 10, 2018—Findings from a national audit in Sweden to study the effect of more expedient carotid interventions on the rate of recurrent ischemic events were published by Björn Kragsterman, MD, et al in European Journal of Vascular and Endovascular Surgery (2018;56:467–474).
Preliminary 3-Year Data From PARADIGM-Extend Trial Evaluate InspireMD's CGuard EPS
September 27, 2018—InspireMD, Inc. announced that findings from the PARADIGM-Extend trial of the company's CGuard MicroNet-covered embolic prevention system (EPS) were presented in a poster at TCT 2018, the Transcatheter Cardiovascular Therapeutics annual scientific symposium held September 21–25 in San Diego, California.
FDA Clears Contego's Paladin Carotid PTA Balloon System With Integrated Embolic Protection
September 18, 2018—Contego Medical, LLC announced that the FDA has granted 510(k) clearance for its Paladin carotid percutaneous transluminal angioplasty (PTA) balloon system, which is a filter-based integrated embolic protection (IEP) device.
Terumo's MicroVention Casper Carotid Stent Evaluated for Safety and Efficacy at 90 Days
August 29, 2018—In a retrospective analysis of prospectively collected data evaluating the safety and efficacy of the Casper carotid stent (MicroVention, Inc., a subsidiary of Terumo), the device demonstrated safety and efficacy in the treatment of carotid stenosis with no technical failures and no adverse neurological events in the 90-day follow-up period.
Study Shows Operator-Adjudicated mTICI Scores Tend to Overestimate Reperfusion After Endovascular Stroke Treatment
August 29, 2018—Operators tend to overestimate the degree of reperfusion compared with the core lab adjudication after endovascular treatment of acute ischemic stroke; however, this does not affect the accuracy of outcome prediction, concluded Guang Zhang, MD, et al for the MR CLEAN registry investigators in a study published online in Stroke.
Sponsored by Silk Road Medical
August 2018 Supplement
US Device Guide
This Device Guides offers a searchable, comprehensive listing of the available vascular interventional devices in the United States.
European Device Guide
This Device Guides offers a searchable, comprehensive listing of the available vascular interventional devices in Europe.