Silk Road Medical has announced the first US commercial procedure using the Enroute transcarotid neuroprotection system was successfully performed at Mills-Peninsula Medical Center in Burlingame, USA by vascular surgeon John E Rosenman.
Transcarotid artery revascularisation, 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. The Enroute transcarotid neuroprotection system recently received 510(k) clearance by the US Food & Drug Administration (FDA).
“The transcarotid artery revascularisation procedure using the Enroute transcarotid neuroprotection system 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,” said Rosenman. “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.”
The FDA cleared the Enroute transcarotid neuroprotection system based on the outcomes of the ROADSTER trial, which achieved a 30 day stroke rate of 1.4% in the pivotal cohort, a rate comparable to the gold standard of a surgical carotid endarterectomy (CEA) and the lowest to date for any prospective trial of carotid artery stenting. There were no major strokes and there were no strokes in important high risk subgroups, including the elderly (age >=75), women, and symptomatic patients.
“The surgical treatment of carotid artery disease to reduce the long term risk of stroke is well established, but many patients have risk factors that can lead to complications as a consequence of the procedure itself, including stroke, death, and cranial nerve injuries,” said Sumaira Macdonald, chief medical officer. “Transcarotid artery revascularisation represents a procedural paradigm shift that brings together key principles of surgical and endovascular techniques to reduce these risks and is a welcome, clinically proven option for physicians and their patients.”
Silk Road Medical will ramp up commercial operations throughout 2015 to broaden US distribution of the Enroute transcarotid neuroprotection system to vascular specialists. The Enroute transcarotid neuroprotection system has been available internationally since 2012 and more than 500 patients have been treated with the device in the US and Europe. The company also has a pending Premarket Approval (PMA) application for the Enroute transcarotid stent system—an optimised stent delivery system designed for use with the Enroute transcarotid neuroprotection system.