This article is more than 5 years old. Information may no longer be current.

FDA clears next-generation transcarotid neuroprotection system

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

Silk Road Medical announced that the FDA has granted 510(k) clearance for its next-generation transcarotid neuroprotection system.

The Enroute Transcarotid Neuroprotection System is indicated for transcarotid artery revascularization. The system allows the physician direct access to the common carotid artery and to initiate high rate temporary blood flow reversal to prevent the brain from stroke while delivering and implanting the Enroute Transcarotid Stent (Silk Road Medical), according to a press release.

Based on design feedback from more than 700 transcarotid artery revascularization procedures, the next-generation system was enhanced and upgraded, according to the release. The first procedures with the new device were performed at US hospitals including the Ronald Reagan UCLA Medical Center in Los Angeles, Beth Israel Deaconess Medical Center in Boston and Heart Hospital of Austin.

“The best prospect for reducing the periprocedural risk of stroke during carotid revascularization has been the transcarotid artery revascularization procedure, and the technical advancements of the new Enroute Transcarotid Neuroprotection System provide us with even more confidence to safely treat patients in a minimally invasive manner,” Wesley Moore, MD, professor and chief (emeritus) in the division of vascular surgery at Ronald Reagan UCLA Medical Center, stated in the release. Moore and Brian DeRubertis, MD, performed the first case using the next-generation device in the United States, according to the release.

In March, the next-generation device received CE Mark approval. The first-generation Enroute system was cleared by the FDA in February 2015.

The new system will be immediately launched in the United States, including in the ongoing ROADSTER 2 postapproval study. ROADSTER 2 is a multicenter study that will assess transcarotid artery revascularization in real-world patients at risk for stroke due to carotid artery disease. At least 600 patients will be enrolled at up to 100 sites, according to the release.

Disclosure: Healio.com could not confirm relevant financial disclosures.