Silk Road Medical Reports Initial United States Commercial Use of Enroute Transcarotid NPS

April 17, 2015—Silk Road Medical, Inc. announced the first commercial procedure in the United States using the Enroute transcarotid neuroprotection system (NPS), which received US Food and Drug Administration 510(k) clearance in February.

Vascular surgeon John E. Rosenman, MD, performed the transcarotid artery revascularization (TCAR) procedure at Mills-Peninsula Medical Center in Burlingame, California.

According to Silk Road Medical, TCAR uses direct carotid artery access and robust, temporary flow reversal to protect the brain from particles that can dislodge during the carotid artery repair procedure. 

In the company’s press release, Dr. Rosenman commented, “The TCAR procedure using the Enroute transcarotid NPS allows me to perform a minimally invasive stent procedure expeditiously with less risk of nerve injury and less trauma to the patient than traditional open surgery. We are excited to be one of the first hospitals in the nation to offer this procedure to our patients with carotid artery disease. We are confident in the effectiveness of flow reversal for stroke prevention during stent placement. The transcarotid approach is a less invasive, more patient friendly option compared to traditional open surgery.”

Silk Road Medical advised that it will accelerate commercial operations throughout 2015 to broaden distribution of the Enroute device in the United States. The Enroute transcarotid NPS has been available internationally since 2012. The company noted that it also has a pending premarket approval application for the Enroute transcarotid stent system, a stent delivery system designed for use with the Enroute transcarotid NPS.