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: 735 North Pastoria Avenue, Sunnyvale, CA 94085
Approval Date: May 18, 2015
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf14/P140026a.pdf
What is it? The ENROUTE Transcarotid Stent System is used to re-open narrowed regions of the carotid arteries in the neck that supply blood to the brain. The implant consists of a self-expanding stent mounted on a delivery catheter system. The stent is made of nickel-titanium alloy (nitinol) tubing, laser-cut into a mesh shape.
This stent is the same as a previously approved stent (Cordis PRECISE Nitinol Stent System - P030047), but the delivery catheter is shorter. This allows doctors to insert the delivery catheter directly into the neck, instead of passing it through the blood vessel in the groin up to the blocked area in the neck.
The ENROUTE Transcarotid Stent System is used with a protection device (ENROUTE Transcarotid Neuroprotection System, also referred to as ENROUTE TNS) that temporarily reverses blood flow at the treatment site to divert particles that may become loose during the procedure from potentially traveling to the brain.
How does it work? The ENROUTE TNS is placed with tubes in the leg and neck connected by a flow controller. This reverses the direction of blood flow at the treatment site in the neck. After the ENROUTE TNS is in place, the doctor inserts the ENROUTE delivery catheter into the neck and moves the stent to the blocked area. The ENROUTE stent is then released from the catheter and opens automatically over the blockage. The stent delivery catheter and ENROUTE TNS are both removed.
When is it used? The ENROUTE Transcarotid Stent System is used together with the ENROUTE TNS in patients who:
- have a high likelihood of complications due to other medical problems or body abnormalities if they had the surgical alternative (called carotid endarterectomy), and
- have had a recent stroke and have at least a moderate (greater or equal to 50%) blockage in the blood vessels of the neck, or
- have not had a recent stroke but have a very large (greater or equal to 80%) blockage in the vessels of the neck.
What will it accomplish? The stent opens blockages in the blood vessel in order to prevent future strokes. In a clinical study, the stent was implanted successfully in 51 out of 52 patients in the United States, with one patient suffering a stroke. In another earlier clinical study in Europe, the stent was successfully implanted in 13 of 13 patients.
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.
- have problems preventing the ENROUTE TNS from being placed properly.
Additional information: The Summary of Safety and Effectiveness Data and labeling are available online.