Silk Road unveils results from ROADSTER-2 study of transcarotid stent
Category: #health  By Pankaj Singh  Date: 2019-06-17
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Silk Road unveils results from ROADSTER-2 study of transcarotid stent

Silk Road Medical, Inc., a medical device company focused on reducing the risk of stroke and its harmful impact, has recently announced positive final results for its ROADSTER-2 post-marketing study which evaluated the real world use of the company’s ENROUTE® Transcarotid Neuroprotection & Stent System in TransCarotid Artery Revascularization (TCAR) procedures.

At the Society for Vascular Surgery’s Vascular Annual Meeting 2019, Chief of Endovascular Therapy and Vascular Surgery at University Hospitals Case Medical Center and National Co-Principal investigator of ROADSTER-2, Dr. Vikram Kashyap, stated that the study had represented compelling patient outcomes.

Dr. Kashyap informed that the study demonstrated combined stroke and death and low stroke rates of 0.8% and 0.6%, in 632 high surgical risk patients registered across 42 sites and out of which 70% of patients registered in the study were from physicians new to TCAR.

Apparently, the results of ROADSTER-2 would continue to represent the effectiveness, safety and clinical benefits of TCAR, specifically given that most of the TCAR procedures were conducted by a wide group of physicians with no former TCAR experience, Dr. Kashyap said.

Sources familiar with the matter mentioned that the study results represent the short learning curve of the TCAR procedure and its notable reproducibility and consistency. The company believes that it will further encourage physicians to widely adopt the TCAR procedure.

Reportedly designed as a follow-on study to the essential ROADSTER trial, ROADSTER-2 is a multi-center, prospective study which is designed to evaluate the real-world usage of the ENROUTE Transcarotid Stent when it is used with the ENROUTE Transcarotid Neuroprotection System by several physicians of different experience with the TCAR procedure.

The study seemingly met its primary endpoint of procedural success, demonstrated as acute device and technical success in the absence of stroke, myocardial infarction (MI) or death at 30 days, at 97.9%, sources added.

 

Source Credit: https://investors.silkroadmed.com/news-releases/news-release-details/roadster-2-demonstrates-compelling-patient-outcomes-strong



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Pankaj Singh

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Pankaj Singh

Pankaj Singh Develops content for Market Size Forecasters, Algosonline, and a couple of other platforms. A Post Graduate in Management by qualification, he worked as an underwriter in the UK insurance domain before deciding to switch his field of profession. With exp...

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