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 trial, which it claims reported the lowest stroke rates in any prospective study of carotid revascularization.
“With over 1,200 patients treated with TCAR worldwide, the peri-procedural outcomes in clinical trials and real world registries are clearly better than any carotid revascularization paradigm for the high surgical risk patient. These outcomes coupled with the groundbreaking Medicare reimbursement option for TCAR recently announced by the Society for Vascular Surgery Patient Safety Organization will further the proliferation of TCAR as a new standard of care in carotid revascularization,” prez & CEO Erica Rogers said in a press release.
In September, Silk Road said that the Centers for Medicare & Medicaid Services granted coverage for transcarotid artery revascularization procedures, including those performed with its Enroute transcarotid neuroprotection and stent system.
The TCAR procedures are now eligible for coverage for patients who are treated with FDA-approved proximal embolic protection devices and approved carotid artery stent systems indicated for transcarotid procedures. The devices are also required to be entered into the national TCAR Surveillance Project, Silk Road Medical said.
The reimbursement change immediately enables coverage for TCAR procedures in hospitals that are part of the Vascular Quality Initiative of the Society for Vascular Surgery’s Patient Safety Organization, Silk Road said. Reimbursement will only be applied for Medicare beneficiaries who are deemed high risk for adverse events from traditional carotid endarterectomy procedures.
In June, Silk Road released new clinical data for the Enroute device. The company said that additional data showed that the system helped improve stroke and death rates in the wake of its FDA sign-off last October.