Silk Road Medical said today that it won FDA pre-market approval for its Enroute transcarotid stent system.
Sunnyvale, Calif.-based Silk Road said the device is indicated for use in high-risk patients in conjunction with its transcarotid neuroprotection system, which recently won 510(k) clearance from the U.S. safety watchdog.
Enroute is the 1st carotid stent designed to be implanted into the carotid artery through a common access point, Silk Road said.
"[Transcarotid artery revascularization] allows us to avoid potential stroke hazards at the aortic arch while placing a stent under robust flow reversal which simulates the superb neuroprotection of [carotid endarterectomy]. With the Enroute transcarotid stent we now have a dedicated, ergonomic stent platform for TCAR that combines the control afforded by transcarotid access with the stent’s visibility under x-ray, allowing for confident, precise stent placement," Dr. Ralf Kolvenbach of Dusseldorf, Germany’s Augusta Hospital said in prepared remarks.
The FDA approval of the stent was based in part on a subset of 52 patients from the Roadster clinical study, according to the company. The subset of patients treated with the Enroute device showed a 100% success rate with a 1.9% rate of major adverse events at 30 days, consisting of a single stroke.
"TCAR was led and inspired by vascular specialists looking for ways to treat their patients with safer and more effective methods. The Enroute transcarotid NPS and stent system is an innovation that will push forward the field of carotid revascularization. Severe carotid artery stenosis is one of the last frontiers in vascular disease that is still treated primarily by an open surgical approach and we look forward to bringing our less invasive, surgically-inspired Enroute transcarotid system to market for vascular specialists and their patients," executive vice president Lucas Buchanan said in a press release.