Solaris Endovascular Receives FDA Breakthrough Device Designation for Drug-Eluting Covered Stent

Solaris Endovascular announced that the U.S. FDA granted Breakthrough Device Designation to its Solaris DE drug-eluting covered stent, designed to improve outcomes in dialysis access and peripheral vascular interventions. The device combines a self-expanding nitinol scaffold, a PTFE barrier, and a sirolimus-eluting coating to reduce edge restenosis and improve long-term vessel patency. The designation is supported by early clinical data from the DEScover trial showing strong 6-month patency rates and no device-related serious adverse events in key patient cohorts.