Solaris Endovascular reports strong 6-month DEScover results for Solaris DE

Solaris Endovascular says its Solaris DE investigational covered stent met its primary safety endpoint and posted high 6-month patency results in the DEScover Phase II study, presented at CIRSE 2026 in Copenhagen. The company also secured ANVISA approval for a new Brazilian study arm testing a higher intermediate sirolimus dose across longer uncovered stent-edge segments.

Why it matters: - Dialysis access dysfunction often leads to repeat procedures, and the DEScover results point to a potential way to improve vessel patency and reduce reintervention burden. - Solaris Endovascular is using the data to support a longer development path for Solaris DE, including U.S. regulatory steps and a planned pivotal study.

What happened: - Solaris Endovascular reported complete 6-month results from the DEScover Phase II study of Solaris DE at CIRSE 2026 in Copenhagen. - Leonardo Harduin, MD, principal investigator of DEScover, presented the findings. - ANVISA approved a new 40-patient arm in Brazil that will test an intermediate sirolimus dose across longer uncovered stent-edge segments.

The details: - Solaris DE posted 92.7% overall target lesion primary patency at six months. - In the randomized AVF cohort, Solaris DE showed 92.0% TLPP versus 65.9% with PTA. - The AVG cohort recorded 93.5% TLPP. - Overall access circuit primary patency reached 79.9% at six months. - In the randomized AVF cohort, Solaris DE showed 81.3% ACPP versus 65.9% with PTA. - The AVG cohort recorded 78.1% ACPP. - The study met its primary safety endpoint, with 97.3% freedom from access- or venous outflow circuit-related safety events at 30 days. - The original DEScover study enrolled 120 patients: 80 AVF patients randomized 1:1 to Solaris DE or PTA, and 40 AVG patients treated with Solaris DE in a single-arm cohort. - DEScover is designed to track safety at 30 days and TLPP at six months, with other patency and safety outcomes through 24 months. - Solaris DE combines a self-expanding nitinol scaffold, an electrospun-PTFE membrane, and controlled sirolimus delivery at uncovered stent edges. - Solaris DE received FDA Breakthrough Device Designation on May 1, 2026, for stenosis in the dialysis outflow circuit at the venous anastomosis of synthetic AV grafts. - The new Brazilian cohort will evaluate whether extending sirolimus delivery across a longer portion of the uncovered stent-edge segments improves clinical benefit. - Solaris Endovascular said the total drug dose in the new arm will be about 2.7 times the initial dose while remaining within sirolimus' therapeutic window. - Solaris Endovascular said Solaris DE remains investigational and is not approved for commercial sale anywhere in the world. - More information

Between the lines: - The data strengthen Solaris Endovascular’s case that drug-eluting covered stents may address a weakness of current covered-stent therapy: edge restenosis. - The ANVISA green light suggests the company is now testing whether more drug coverage at the stent edges can further improve durability. - The results also give Solaris Endovascular additional momentum as it looks toward FDA IDE approval and a U.S. pivotal trial.

What's next: - The expanded DEScover program will add a 40-patient single-arm AVF cohort in Brazil. - Solaris Endovascular expects to continue advancing toward FDA IDE approval and initiation of a U.S. pivotal study for Solaris DE. - DEScover will continue collecting outcomes through 24 months.