Solaris DE Covered Stent for Dialysis Access Evaluated in 6-Month DEScover Data

September 8, 2026—Solaris Endovascular, Inc. announced complete 6-month results from the DEScover study evaluating the company’s investigational Solaris DE sirolimus-eluting covered stent for dialysis access dysfunction.

Leonardo Harduin, MD, Principal Investigator of DEScover, presented the results at CIRSE 2026 in Copenhagen, Denmark. Dr. Harduin is a vascular surgeon at the State University of Rio de Janeiro in Rio de Janeiro, Brazil.

According to the company, the Solaris DE device demonstrated excellent patency across both arteriovenous fistula (AVF) and arteriovenous graft (AVG) patients, with results exceeding those previously reported with conventional covered stents and balloon-based therapies. The study also met its primary safety endpoint.

Solaris Endovascular stated that DEScover is a prospective, multicenter, phase 2 feasibility study evaluating Solaris DE in patients with failing hemodialysis access circuits.

The original 120-patient study enrolled 80 patients with AVF, randomized 1:1 to Solaris DE or percutaneous transluminal angioplasty (PTA), and 40 patients with AVG treated with Solaris DE in a single-arm cohort, noted the company.

Solaris Endovascular advised that the study’s primary endpoints evaluated safety at 30 days and TLPP at 6 months, with additional patency and safety outcomes assessed through 24 months.

The following data were outlined in the company’s press release:

• Overall target lesion primary patency (TLPP) was 92.7% with Solaris DE; in the randomized AVF cohort, TLPP was 92.0% with Solaris DE versus 65.9% with PTA, and in the single-arm AVG cohort, TLPP was 93.5%.
• Overall access circuit primary patency (ACPP) was 79.9% with Solaris DE; in the randomized AVF cohort, ACPP was 81.3% with Solaris DE versus 65.9% with PTA, and in the single-arm AVG cohort, ACPP was 78.1%.
• The primary safety endpoint was met, with 97.3% freedom from access- or venous outflow circuit-related safety events at 30 days.

Solaris Endovascular also announced that it received approval from ANVISA, Brazil’s regulatory authority, for a new 40-patient, single-arm AVF cohort evaluating an intermediate sirolimus dose across longer, uncovered stent-edge segments. The total drug dose will be approximately 2.7x the initial dose while remaining within sirolimus’ broad therapeutic window. The new arm will evaluate the potential clinical benefit of extending sirolimus delivery across a longer portion of the uncovered stent-edge segment, noted the company.