Silk Road Medical said today it launched its Enroute Transcarotid stent system in the U.S., and that the stent was used in its 1st commercial commercial case.
The Enroute stent is indicated for use in patients at high surgical risk in conjunction with the company’s transcarotid Neuroprotection system, the Sunnyvale, Calif.-based company said. The stent is also the 1st designed to be implanted into the carotid artery through a common access point.
“The minimally invasive TCAR procedure allows me to safely and quickly treat a carotid artery blockage while minimizing the potential for nerve injury and cardiovascular trauma that can be more frequent in open surgical repair. We know carotid stents are durable if we can deliver them safely. The ergonomics of the Enroute Transcarotid Stent combined with direct carotid access and flow reversal allows me to place the stent with a high level of precision while avoiding many of the potential stroke hazards that have been the Achilles heel of transfemoral carotid artery stenting,” Dr. Peter Schneider of Honolulu, HI.’s Kaiser Permanente Moanalua Medical Center said in a press release.
In May, Silk Road 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.
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.