Silk Road Medical today released results from studies of its transcarotid artery revascularization procedure, touting favorable outcomes in treating patients with carotid artery disease.
Data from the studies were presented at the Society for Vascular Surgery 2018 Vascular Annual Meeting in Boston.
The transcarotid artery revascularization procedure uses the Sunnyvale, Calif.-based company’s Enroute transcarotid stent and neuroprotection system, and is intended to treat blockages in the carotid artery that are at risk of causing a stroke.
Results from a two-year study which compared outcomes from 1,182 patients who received treatment with the TCAR procedure to 10,797 patients who received carotid endarterectomy indicated comparable rates of in-hospital stroke or death between the two at 1.6% versus 1.4%, respectively.
Data also indicated lower rates of acute cranial nerve injury for TCAR at 0.6% versus a 1.8% rate in CEA patients, shorter operative times at 78 minutes and 111 minutes, respectively, and shorter hospital stays for TCAR patients despite increased age and sickness factors versus the CEA cohort.
Results from a separate study comparing TCAR with CEA indicated similar results, with 30-day stroke rates of 1% in TCAR versus 1.1% in CEA. Acute and six-month cranial nerve injury rates were also shown to be smaller in the TCAR cohort than CEA.
“Our overall findings showed that while patients receiving TCAR were sicker and more likely to be symptomatic with a higher degree of stenosis, the stroke and death rate compared to CEA was the same. With TCAR, there were significantly lower cranial nerve injuries, less time spent in the operating room and fewer patients with a prolonged length of stay. I believe that clinicians should more widely adopt the TCAR technology as it has demonstrated both safety and efficacy and is an excellent alternative to CEA,” study presenter Dr. Marc Schermerhorn of Beth Israel Deaconess Medical Center said in a press release.
An interim update on the company’s Roadster 2 post-market study trial indicated a 30-day stroke rate of 0.6% and stroke or death rate of 0.9% with 470 patients of an expected 600 patients enrolled.
“The large body of real-world data presented at VAM18 demonstrates that TCAR can achieve neuroprotection similar to CEA despite being performed in sicker, more frail and ‘at-risk’ patients. These results reiterate the compelling data previously published in the Roadster pivotal trial. Carotid endarterectomy has been the gold standard for 65 years, but with the growing body of evidence, the medical community is showing that TCAR is fulfilling the promise of a less invasive, more efficient, and more patient friendly procedure,” prez & CEO Erica Rogers said in a prepared statement.
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