Solaris DE Drug-Eluting Covered Stent Receives FDA Breakthrough Device Designation

May 5, 2026—Solaris Endovascular, Inc. announced that the FDA has granted Breakthrough Device designation for its Solaris DE drug-eluting covered stent.

The company stated that the Solaris DE is indicated for use in hemodialysis patients for the treatment of stenosis within the dialysis outflow circuit at the venous anastomosis of a synthetic arteriovenous graft (AVG) in the veins of the arm.

According to Solaris Endovascular, Solaris DE is specifically designed to address edge restenosis, a primary driver of stent failures in dialysis access and other vascular beds. The device combines a self-expanding nitinol scaffold, an impermeable electrospun polytetrafluoroethylene barrier, and a targeted sirolimus-eluting coating at the stent edges to inhibit neointimal hyperplasia and improve long-term vessel patency.

Solaris Endovascular advised that the FDA’s designation is anchored by the preliminary results of the phase 2 multicenter DEScover clinical trial demonstrating 100% target lesion primary patency at 6 months in the AVG cohort.

In January 2026, the company announced that the DEScover clinical trial had completed enrollment and noted that interim 6-month data were presented at TCT 2025.

Full results from the DEScover multicenter trial will be presented at a forthcoming scientific forum, advised the company.

Solaris DE is positioned to leverage the newly announced Centers for Medicare & Medicaid Services and FDA RAPID (Regulatory Alignment for Predictable and Immediate Device) coverage pathway, which is designed to enable national Medicare coverage in as little as 2 months after FDA authorization, compared to approximately ≥ 1 year under previous processes.

Solaris Endovascular advised that it continues to work with the FDA to initiate a United States pivotal study and advance the Solaris DE toward premarket approval as a solution for dialysis access and peripheral vascular disease.