First Commercial Case Performed With Silk Road Medical's Enroute Transcarotid Stent System

October 6, 2015—Silk Road Medical, Inc. announced the first commercial case in the United States using the company's Enroute transcarotid stent system. Peter A. Schneider, MD, successfully performed the procedure at Kaiser Permanente Moanalua Medical Center in Honolulu, Hawaii.

In May 2015, Silk Road Medical announced that the US Food and Drug Administration granted premarket approval for the Enroute transcarotid stent.

According to the company, the Enroute device is designed specifically for transcarotid artery revascularization (TCAR), which 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 company’s Enroute transcarotid neuroprotection system (NPS) during the procedure. The Enroute transcarotid NPS, which received FDA clearance in February 2015, is 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.

In Silk Road Medical’s press release, Dr. Schneider commented, “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. 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 company advised that FDA approval for the Enroute transcarotid stent was based in part on data collected from a 52-patient subset of the 141 high-surgical-risk patients in the 283-patient ROADSTER study who were treated with the Precise Pro RX stent system (Cordis Corporation) 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 a 3.5% MAE rate and a 1.4% stroke rate.

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 across multiple clinical trials including SAPPHIRE, CASES-PMS, and SAPPHIRE Worldwide, stated Silk Road Medical.