The first US commercial case using Silk Road Medical’s Enroute transcarotid stent system has been successfully performed at Kaiser Permanente Moanalua Medical Center in Honolulu, Hawaii, by vascular surgeon Peter A Schneider. The Enroute transcarotid stent is designed specifically for transcarotid artery revascularisation (TCAR), combining the surgical principles of neuroprotection with minimally invasive endovascular techniques to treat blockages in the carotid artery at risk of causing a stroke.
Enroute is indicated for use in high surgical risk patients and is intended to be used in conjunction with the Enroute 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.
“The minimally invasive TCAR procedure allows me to safely and quickly treat a carotid artery blockage while minimising the potential for nerve injury and cardiovascular trauma that can be more frequent in open surgical repair,” said Schneider. “We know carotid stents are durable if we can deliver them safely. The ergonomics of the Enroute stent combined with direct carotid access and flow reversal allows me to place the stent with a high level of precision while avoiding many of the potential stroke hazards that have been the Achilles heel of transfemoral carotid artery stenting.”
The Enroute stent was granted Premarket Approval (PMA) from the US Food and Drug Administration (FDA) in May 2015 based in part on data collected from a subset (n=52) of 141 high surgical risk patients in the ROADSTER study who were treated with the Cordis Precise Pro RX stent system and the Enroute transcarotid NPS. Technical success was 100% and the major adverse event rate at 30 days was 1.9%, consisting of a single minor stroke, comparable to the overall ROADSTER results of 3.5% major adverse event and 1.4% stroke. The 1.4% 30-day stroke rate was the lowest seen to date of any contemporary prospective trial of carotid stenting.
The Enroute stent was developed pursuant to a license with Cordis and leverages the micromesh design and long term durability of the Cordis Precise carotid stent that was clinically proven in tens of thousands of patients across multiple clinical trials including SAPPHIRE, CASES-PMS and SAPPHIRE Worldwide.