Enrollment milestone achieved ahead of schedule as Solaris DE drug-eluting continues to gather additional clinical evidence of safety and performance.
NEW ORLEANS, LA, UNITED STATES, January 8, 2026 /EINPresswire.com/ — Solaris Endovascular, Inc., a medical device company developing next-generation covered stent technologies, today announced that the DEScover Clinical Trial has successfully completed enrollment.
DEScover is a prospective, multicenter clinical study evaluating the Solaris DE sirolimus-eluting, electrospun PTFE covered stent for the treatment of vascular disease in dialysis access circuits. The study includes both native AVF and prosthetic AVG patients and is designed to evaluate safety and Target Lesion Primary Patency (TLPP) outcomes compared with standard percutaneous transluminal angioplasty (PTA) in AVF and single-arm treatment in AVG.
“Completing DEScover enrollment ahead of schedule was an important scientific and clinical milestone” said Leonardo Harduin, MD, Principal Investigator. “Based on what we’ve seen so far, Solaris DE has the potential to be the long-awaited solution to vascular access patency.”
Interim six‑month data from the DEScover trial presented at TCT 2025 demonstrated 95% overall TLPP, including 100% patency in the AVG cohort and 91% patency in AVF patients treated with Solaris DE, with no device‑related serious adverse events reported at 30 days.
“These results, combined with rapid enrollment progress, reinforce the potential high impact and clinical value of pairing a modern self‑expanding platform with an electrospun PTFE barrier and controlled local drug delivery,” said Marco Costa, MD, PhD, Chief Scientific & Medical Officer, Solaris Endovascular. “We look forward to sharing full results as follow‑up matures.”
About the DEScover Trial
DEScover is evaluating whether a sirolimus-eluting covered stent can meaningfully reduce edge restenosis and the need for repeat interventions in dialysis access circuits.
Building on the Solaris SX platform, the Solaris DE design uniquely integrates:
• Mechanical scaffold: self-expanding nitinol frame for precision and durability
• Structural barrier: electrospun PTFE membrane to block neointimal cell migration
• Biological barrier: controlled sirolimus release over 60 days at the stent edges to inhibit smooth-muscle proliferation in the vessel wall.
Solaris DE delivers sirolimus directly to the vessel wall, with the goal of extending patency beyond the stent edge as patients are followed through 12 months and beyond.
About Solaris Endovascular
Solaris Endovascular, Inc. is a privately held medical device company developing advanced covered stent technologies to treat restenosis in peripheral artery disease and dialysis access. The company’s Solaris SX platform is commercially available in multiple global markets, while Solaris DE is currently under clinical evaluation and is not approved for sale in the United States.
Randolph Hubbell
Solaris Endovascular, Inc
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