Solaris Endovascular to Present 6-Month DEScover Data at CIRSE 2026

Solaris Endovascular will present complete 6-month results from its DEScover Phase II study of the investigational Solaris DE stent on Sept. 5 at CIRSE 2026 in Copenhagen. Interim data showed 95% target lesion primary patency and 82% access circuit primary patency at six months in patients with failing hemodialysis access circuits.

Why it matters: - Solaris DE is being studied for dialysis access dysfunction, a condition that can threaten the function of hemodialysis access circuits. - The complete 6-month dataset could give physicians a fuller read on whether the device’s drug-eluting covered-stent design improves patency in both fistula and graft patients. - Solaris DE received FDA Breakthrough Device Designation on May 1, 2026, for stenosis in the dialysis outflow circuit at the venous anastomosis of synthetic arteriovenous grafts.

What happened: - Solaris Endovascular said complete 6-month results from the DEScover Phase II study will be presented at CIRSE 2026 in Copenhagen. - Principal Investigator Leonardo Harduin, MD, will present the data on Saturday, Sept. 5, 2026. - DEScover is a prospective, multicenter Phase II feasibility study of the investigational Solaris DE sirolimus-eluting covered stent in patients with failing hemodialysis access circuits. - The study enrolled 120 patients in total. - Eighty patients had arteriovenous fistulae and were randomized 1:1 to Solaris DE or percutaneous transluminal angioplasty. - Forty patients had arteriovenous grafts and were treated with Solaris DE in a single-arm cohort.

The details: - Interim results previously reported 95% Target Lesion Primary Patency and 82% Access Circuit Primary Patency at six months among Solaris DE-treated patients. - Solaris DE combines a self-expanding nitinol scaffold, an electrospun-PTFE membrane and controlled sirolimus delivery at the uncovered stent edges. - The scaffold is engineered for precise deployment and durability. - The membrane acts as a structural barrier to neointimal cell migration. - The sirolimus delivery is intended to inhibit smooth-muscle proliferation and address edge restenosis. - Solaris Endovascular said the complete 6-month DEScover dataset will be presented publicly for the first time at CIRSE. - The presentation comes from a device that is investigational and not approved for commercial sale anywhere in the world.

Between the lines: - The trial design splits the evidence base between randomized fistula patients and a single-arm graft cohort, which should help show where the device may perform best. - The interim patency numbers are encouraging, but the upcoming presentation matters because complete follow-up can clarify durability and consistency across the full study population. - The company is positioning Solaris DE as a next-generation option aimed at edge restenosis, one of the persistent limitations of covered stent therapy.

What's next: - Harduin will present the complete dataset to the international vascular community at CIRSE 2026. - The presentation could shape expectations for later-stage development and possible regulatory planning if the full results hold up. - Solaris Endovascular continues to develop Solaris DE alongside its marketed Solaris SX platform outside the United States.

The bottom line: - Solaris Endovascular is moving its investigational dialysis-access stent closer to a more complete efficacy readout, with the full 6-month DEScover results set to test whether strong interim patency can translate into broader clinical confidence.