US-based Silk Road Medical has received CE mark approval for its next generation Enroute transcarotid neuroprotection system (NPS).
The device is specifically designed to carry out clinical procedure known as transcarotid artery revascularization (TCAR).
TCAR aggregates surgical principles of neuroprotection with minimally invasive endovascular techniques to treat blockages in the carotid artery at risk of causing a stroke.
Enroute system enables the physician to directly access the common carotid artery in the neck and start high rate temporary blood flow reversal to protect the brain from stroke while delivering and implanting the firm’s Enroute transcarotid stent.
The company said the first TCAR procedures with the new Enroute NPS were recently carried out in European hospitals including the Virgen de la Salud Hospital in Toledo of Spain and Klinikum rechts der Isar in Munich and Augusta Krankenhaus in Dusseldorf of Germany.
Virgen de la Salud hospital vascular surgery chief Antonio Orgaz said: "We have been working to improve the safety profile of carotid revascularization through the development of the TCAR procedure, and this latest design of the Enroute NPS for TCAR is state-of-the-art.
"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."