This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: ENROUTE Transcarotid Stent System
PMA Applicant: Silk Road Medical, Inc.
Address: 1213 Innsbruck Drive, Sunnyvale, CA 94089
Approval Date: April 28, 2022
Approval Letter: Approval order
What is it?
The ENROUTE Transcarotid Stent System is used to re-open narrowed parts of the neck arteries that supply blood to the brain (carotid arteries). The implant consists of a self-expanding stent and a delivery catheter system. The stent is made of nickel-titanium alloy (nitinol) tubing, laser-cut into a mesh shape.
The ENROUTE Transcarotid Stent System was previously approved to treat patients at high risk for complications from surgery. This approval expands the indication for use to include treatment of patients with a normal risk of complications from surgery for this condition.
How does it work?
The ENROUTE Transcarotid Stent System is used with a protection device called the ENROUTE Transcarotid Neuroprotection System (ENROUTE NPS). The ENROUTE NPS is placed first and is used to temporarily reverse blood flow at the treatment site and prevent any loose particles in the blood from traveling to the brain.
After the ENROUTE NPS is in place, a doctor inserts the ENROUTE Stent System delivery catheter into a small cut in the neck area and moves it to the blocked area. The ENROUTE stent is released from the catheter and opens automatically over the blockage. Once the stent is in place, the delivery catheter and ENROUTE NPS are both removed.
When is it used?
The ENROUTE Transcarotid Stent System is used together with the ENROUTE NPS in patients who have a normal likelihood of complications if they were to have surgery to correct their carotid artery disease (carotid endarterectomy) and either:
- A recent stroke with at least a moderate blockage (50% to 70%) in the blood vessel or
- No recent stroke but a large blockage (60% to 70%)
What will it accomplish?
The ENROUTE stent holds open the carotid arteries that have blockages to prevent future strokes. Real-world data collected from a patient registry showed that 2,962 patients who received the ENROUTE Transcarotid Stent System and ENROUTE NPS together did no worse than 8,886 similar patients who received the surgical treatment instead. The patients who were compared all had similar normal risks for surgery complications.
When should it not be used?
The ENROUTE Transcarotid Stent System should not be used in patients who:
- Cannot take blood thinners or who have bleeding disorders
- Are allergic to nitinol
- Have blockages at the beginning of the neck artery (carotid artery)
- Have other issues that may prevent the ENROUTE NPS and ENROUTE Stent System from being placed