Silk Road Medical has announced the completion of enrolment in its pivotal ROADSTER study. The trial was the first of its kind to study the treatment of carotid artery stenosis by placing a stent via direct access to the common carotid artery in the neck in an entirely new minimally invasive procedure. The device under study is the company’s Enroute transcarotid neuroprotection system which incorporates proven surgical principles to protect the brain from a stroke during carotid angioplasty and stenting, and features a mechanism to divert dangerous debris away from the brain by temporarily reversing blood flow. Data from the trial will be used to support 510(k) clearance of the Enroute transcarotid neuroprotection system as well as pre-market approval of the Enroute transcarotid stent system.
“The Enroute transcarotid neuroprotection system was designed to reduce the excess stroke risk of a carotid stent procedure, while at the same time minimising the surgical risks of an open carotid artery surgery known as carotid endarterectomy,” says Sumaira Macdonald an expert in the field of carotid artery disease and Silk Road Medical’s chief medical officer. “Until now, carotid stents were typically placed via the femoral artery approach, which is about three feet from the culprit carotid stenosis, and requires navigation of catheters and other instruments through often hostile territory, increasing the risk of stroke during or immediately after the procedure,” she says. “We know that carotid stents are effective in preventing strokes in the long term, but we need a safer way to deliver them. The Silk Road procedure moves the access point to within inches of the stenosis to avoid at-risk steps and provides a surgically-inspired method of protecting the brain throughout the simplified procedure.”
By contrast, the gold standard carotid endarterectomy procedure requires a large incision in the neck and a surgery that carries some risk of nerve damage, bleeding, scarring and infection. The Silk Road procedure is designed to reduce these surgical risks as well. “Historically, there has not been a safe and effective minimally invasive procedure that could hold up to the clinical outcomes established by carotid endarterectomy. This new procedure may be it,” says Richard Cambria, chief, Division of Vascular and Endovascular Surgery at Massachusetts General Hospital and The Robert R Linton MD Professor of Vascular and Endovascular Surgery at the Harvard Medical School. “The results from our centre will be announced at the VEITH Symposium.” Cambria serves as the National co-principal investigator for the ROADSTER trial.
“The ROADSTER trial included an elite, multi-disciplinary group of physicians across the US and Europe with vast experience in treating carotid disease,” says Christopher Kwolek, director of the Vascular and Endovascular training programme at Massachusetts General Hospital, chief of Vascular Surgery at Newton Wellesley Hospital, and National co-principal investigator for the ROADSTER trial. “Similar to important endovascular innovations in aortic aneurysms and peripheral arterial disease, this new minimally invasive procedure will be an important step forward in the treatment of carotid artery disease for the vascular specialist.”
Erica Rogers, chief executive officer for Silk Road Medical, comments, “We believe the ROADSTER data will support clearance and approval of our planned marketing applications with the FDA. We are grateful for the collaboration of our investigators who allowed this study to complete enrolment on time. We are quite eager to present the full results of the study in the near future.”
Both the Enroute transcarotid neuroprotection system and stent system have been granted CE mark approval. The Enroute transcarotid neuroprotection system is limited by United States law to investigational use. The Enroute transcarotid stent system is not currently available in the United States.