SUNNYVALE, Calif., Sept. 15, 2016 /PRNewswire/ -- Silk Road Medical, Inc., a company dedicated to surgical and endovascular innovation to prevent the devastating burden of stroke, announced the Centers for Medicare and Medicaid Services (CMS) has extended coverage for the TransCarotid Artery Revascularization (TCAR) procedure under the existing National Coverage Determination 20.7. TCAR is eligible for coverage when patients are treated with any FDA-approved proximal embolic protection device and FDA-approved carotid artery stent system indicated for the transcarotid approach and entered into the new national TCAR Surveillance Project. The TCAR Surveillance Project is sponsored by the Society for Vascular Surgery (SVS) Patient Safety Organization (PSO) and has been deemed scientifically valid and clinically relevant by the Food and Drug Administration (FDA).
As outlined on the CMS Carotid Artery Stenting (CAS) Investigational Studies web page, this decision is effective immediately and provides coverage for TCAR procedures in hospitals participating in the Vascular Quality Initiative (VQI) of the SVS PSO. Reimbursement for TCAR will apply to Medicare beneficiaries who are deemed to be high risk for adverse events from traditional carotid revascularization surgery, also known as carotid endarterectomy.
"We applaud the Society of Vascular Surgery for leading the discussions with CMS and FDA to establish this national surveillance project to provide Medicare beneficiaries access to a clinically proven, less invasive therapeutic option while broadening the real world evidence base for TCAR," said Erica Rogers, CEO of Silk Road Medical, "we look forward to ongoing publications from this data base that support our overarching goal of reducing the morbidity and mortality associated with treating carotid artery disease."
The TCAR Surveillance Project is a prospective, national, open ended observational registry. Hospitals and physicians participating in the VQI of the SVS PSO can obtain coverage for TCAR procedures by submitting claims under the National Clinical Trial (NCT02850588) as listed on ClinicalTrials.gov.
The ENROUTE® Transcarotid Neuroprotection and Stent System are the first and currently only devices approved for the TCAR procedure by the U.S. Food and Drug Administration (FDA).
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 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.
Click here to find more information on the SVS PSO.
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.
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SOURCE Silk Road Medical, Inc.