Silk Road Medical has been granted CE approval for its Enroute transcarotid neuroprotection system (NPS). The company has also reported the first patients have been treated with the system.
The Enroute NPS is specifically designed and indicated for transcarotid artery revascularisation (TCAR).
Silk Road Medical developed the next-generation system in partnership with treating physicians. Based on feedback from over 700 TCAR procedures, the Enroute NPS was upgraded to provide physicians with a more dependable and easy-to-use system to treat their patients as safely as possible. The Enroute NPS allows the 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 first TCAR procedures with the new Enroute NPS were recently performed in European hospitals including the Virgen de la Salud Hospital in Toledo, Spain, Klinikum rechts der Isar (Technische Universität München) in Munich, Germany, Augusta Krankenhaus in Dusseldorf Germany, John Paull II Hospital in Krakow, Poland and Gent University Hospital in Gent, Belgium.
“We have been working to improve the safety profile of carotid revascularisation through the development of the TCAR procedure, and this latest design of the Enroute NPS for TCAR is state-of-the-art,” says Antonio Orgaz, chief of Vascular Surgery from Virgen de la Salud Hospital. “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.”
The first generation Enroue NPS was clinically proven in the ROADSTER clinical trial, and the data were published in the November 2015 issue of the Journal of Vascular Surgery where the authors conclude, “The overall stroke rate of 1.4% is the lowest reported to date for any prospective, multi-centre clinical trial of carotid angioplasty and stenting.” The next generation Enroute NPS has been designed with the same flow rate specifications to maintain the neuroprotection seen in the ROADSTER trial, according to a company release.
“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,” says Ralf Kolvenbach, director, Department of Vascular Surgery and Endovascular Therapy at Augusta Krankenhaus. “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 manoeuvres, 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.”