Silk Road touts low stroke rate in 2 studies of Enroute TCAR system

Silk Road Medical yesterday released data from 2 studies of its Enroute transcarotid neuroprotection and stent system, including 1-year data from a pivotal trial of the device and an interim analysis of a post-approval study of the Enroute. Data from the studies was presented last month at the 44th annual Veith Symposium in New York. The Sunnyvale, Calif.-based company touts the Enroute system and stent as the 1st and only devices currently approved for transcarotid artery revascularization procedures by the FDA. Silk Road presented data from the Roadster 1 pivotal trial of the TCAR system, which examined the use of the device in high risk patients with carotid stenosis. Results in the trial indicated a 1.1% rate of ipsilateral stroke at 1-year, the company said. Data collection is slated to continue for the cohort, the company said, and will be published upon completion. Data was also presented from the company’s Roadster 2 study, a post-market registry examining high risk patients with carotid stenosis treated with the Enroute device. Data from the interim analysis indicated a procedural success rate, as defined by acute device and technical success in the absence of stroke, death or myocardial infarction, was 97.5% at 30 days. Stroke and death rate in patients examined in the study at 30 days were 1.3% and 1% for all patients enrolled in the study, the company said. The company touted the rates, saying the outcomes are “on par” with its Roadster 1 t...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Clinical Trials Vascular Silk Road Medical Inc. Source Type: news