CE Mark Approved for Silk Road’s Next-Generation Enroute Transcarotid NPS
March 15, 2016—Silk Road Medical, Inc. announced European CE Mark approval for its next-generation Enroute transcarotid neuroprotection system (NPS), which is designed and indicated for transcarotid artery revascularization (TCAR).
According to the company, the Enroute NPS allows the treating physician to directly access the common carotid artery in the neck and initiate high-rate temporary blood flow reversal to protect the brain from stroke while delivering and implanting Silk Road’s Enroute transcarotid stent. The current Enroute NPS upgrades aim to enhance ease of use of the system, which Silk Road describes as having the same flow rate specifications to maintain the results seen in the pivotal ROADSTER clinical trial, which supported FDA approval of the first-generation Enroute NPS.
The first TCAR procedures with the new Enroute NPS were recently performed in leading European hospitals including Virgen de la Salud Hospital in Toledo, Spain; Technische Universität München in Munich, Germany; Augusta Krankenhaus in Dusseldorf, Germany; John Paul II Hospital in Krakow, Poland; and Gent University Hospital in Gent, Belgium.
Commenting in the company's announcment, Antonio Orgaz, MD, Chief of Vascular Surgery from Virgen de la Salud Hospital, discussed collaborative efforts to improve the safety profile of carotid revascularization through the development of the TCAR procedure. "We were extremely impressed with the smooth, atraumatic entry of the sheath into the carotid artery and the more ergonomic design of the overall system. It is easy to use and inspires confidence,” he said.
Prof. Ralf Kolvenbach, MD, who is Director, Department of Vascular Surgery and Endovascular Therapy at Augusta Krankenhaus, also offered his thoughts on the advantages of this approach. “Whereas elsewhere in the body we routinely use minimally invasive endovascular techniques to treat vascular disorders, carotid artery disease is one of the last frontiers that is still treated primarily by an invasive surgical approach," he commented. "This is because techniques used during carotid surgery are very good at protecting the brain during the procedure. With the Enroute NPS we can leverage surgical principles of neuroprotection like avoiding unprotected maneuvers, maintaining exquisite control of the carotid bifurcation and blood flow, and removing embolic fragments of any size. But we can now do it in a less-invasive manner that mitigates the risks of surgical complications like cranial nerve injury and wound complications while providing the patient with an aesthetic result and a quicker recovery.”
In February 2015, the US Food and Drug Administration (FDA) cleared the first-generation Enroute transcarotid NPS, and in May 2015, the company announced FDA premarket approval for its Enroute transcarotid stent system. Before that, the first-generation Enroute systems were available in Europe.
The 30-day safety and efficacy data from ROADSTER were published in November 2015 by Christopher J. Kwolek, MD, et al in the Journal of Vascular Surgery (2015;62:1227–1234). In this publication, the investigators concluded, “The overall stroke rate of 1.4% is the lowest reported to date for any prospective, multicenter clinical trial of carotid angioplasty and stenting.”