Silk Road Medical Announces First U.S. Commercial Case with the ENROUTE® Transcarotid Stent System
World’s First Transcarotid Stent Delivery System Designed for the Clinically Proven TransCarotid Artery Revascularization (TCAR) Procedure
SUNNYVALE, Calif., Oct. 6, 2015 /PRNewswire/ — Silk Road Medical, Inc. announced the first U.S. commercial case using the ENROUTE Transcarotid Stent System was successfully performed at Kaiser Permanente Moanalua Medical Center in Honolulu, HI, by Vascular Surgeon Peter A. Schneider, M.D. The ENROUTE Transcarotid Stent is the first and only carotid stent designed specifically for a new procedure called TransCarotid Artery Revascularization, or TCAR. TCAR combines surgical principles of neuroprotection with minimally invasive endovascular techniques to treat blockages in the carotid artery at risk of causing a stroke.
The ENROUTE Transcarotid Stent is indicated for use in High Surgical Risk patients and is intended to be used in conjunction with the ENROUTE Transcarotid 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 minimizing the potential for nerve injury and cardiovascular trauma that can be more frequent in open surgical repair,” said Dr. Schneider. “We know carotid stents are durable if we can deliver them safely. The ergonomics of the ENROUTE Transcarotid 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 Transcarotid Stent was granted Premarket Approval (PMA) from the United States Food & Drug Administration (FDA) in May of 2015 based in part on data collected from a subset (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% (52/52) and the Major Adverse Event (MAE) rate at 30 days was 1.9% consisting of a single minor stroke, comparable to the overall ROADSTER results of 3.5% MAE 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 Transcarotid Stent was developed pursuant to a license with Cordis Corporation 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.
About Silk Road Medical
Silk Road Medical, Inc. is a private company located in Sunnyvale, CA, that develops and manufactures less-invasive medical devices intended to improve the treatment of carotid artery disease through proprietary transcarotid therapies. Detailed information can be found at www.silkroadmed.com.
ENROUTE is a registered trademark of Silk Road Medical, Inc. CORDIS® and PRECISE® are registered trademarks of Cordis Corporation. Third party trademarks used herein are trademarks of their respective owners.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Please refer to package insert for indications, contraindications, warnings, precautions, and instructions for use.
SOURCE Silk Road Medical