Complete 6-Month DEScover Results for Solaris DE to be Presented at CIRSE 2026

Complete dataset follows encouraging interim results demonstrating 95% TLPP and 82% ACPP with investigational Solaris DE

DALLAS, TX, UNITED STATES, September 1, 2026 /EINPresswire.com/ — Solaris Endovascular, Inc., a growth-stage medical technology company advancing next-generation covered stent technologies, today announced that complete 6-month results from the DEScover Phase II study evaluating the investigational Solaris DE sirolimus-eluting covered stent for dialysis access dysfunction will be presented at CIRSE 2026 in Copenhagen. Principal Investigator Leonardo Harduin, MD, will present the data on Saturday, September 5, 2026.

DEScover is a prospective, multicenter Phase II feasibility study evaluating Solaris DE in patients with failing hemodialysis access circuits. The original 120-patient study includes 80 patients with arteriovenous fistulae (AVF), randomized 1:1 to Solaris DE or percutaneous transluminal angioplasty (PTA), and 40 patients with arteriovenous grafts (AVG) treated with Solaris DE in a single-arm cohort. Previously reported interim results demonstrated 95% Target Lesion Primary Patency (TLPP) and 82% Access Circuit Primary Patency (ACPP) at six months among Solaris DE-treated patients. The complete 6-month DEScover dataset will be presented for the first time at CIRSE.

Solaris DE represents a new therapeutic category in vascular access, combining three synergistic technologies: a self-expanding nitinol scaffold engineered for precise deployment and durability; a next-generation electrospun-PTFE membrane that provides a structural barrier to neointimal cell migration; and controlled sirolimus delivery at the uncovered stent edges to inhibit smooth-muscle proliferation and address edge restenosis. Solaris DE received Breakthrough Device Designation from the FDA on May 1, 2026, for the treatment of stenosis within the dialysis outflow circuit at the venous anastomosis of synthetic arteriovenous grafts.

“The interim DEScover results were highly encouraging and demonstrated the potential of this differentiated approach to improve patency in vascular access,” said Leonardo Harduin, MD, Principal Investigator of DEScover and vascular surgeon at the State University of Rio de Janeiro (UERJ). “The complete 6-month dataset will provide a more comprehensive assessment of Solaris DE across both AVF and AVG patients, and we look forward to sharing the results with the international vascular community at CIRSE.”

About Solaris Endovascular
Solaris Endovascular, Inc. is a U.S.-based growth-stage medical technology company developing and commercializing next-generation endovascular covered stent technologies for patients with dialysis access dysfunction and peripheral artery disease. Its portfolio includes Solaris SX, a self-expanding electrospun-PTFE covered stent marketed outside the United States, and Solaris DE, an investigational sirolimus-eluting covered stent designed to address edge restenosis, a persistent limitation of current covered stent therapy.

Building on its proven covered stent platform and innovative drug-eluting technology, Solaris Endovascular is committed to advancing vascular care and improving long-term patient outcomes.

Solaris DE is an investigational device and is not approved for commercial sale anywhere in the world.

Randolph Hubbell
Solaris Endovascular, Inc
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