Solaris Endovascular had a good week in Copenhagen. On September 8, the company presented complete six-month results from DEScover, its 120-patient study of the Solaris DE covered stent, at CIRSE 2026, the largest interventional radiology congress in Europe. Principal investigator Leonardo Harduin, MD, delivered the data from the podium. The short version: the device kept 92.7% of treated lesions open at six months, and in a randomized head-to-head it beat the standard of care by 26 points.
What the numbers mean
Some context first. Hemodialysis only works if blood can move in and out of the body quickly, so surgeons build a dedicated access point: a fistula or a graft, usually in the arm. These access circuits fail constantly. The vessel narrows, flow drops, and the patient is back on the table. The usual fix is balloon angioplasty: reopen the vessel and hope it stays open. Often it doesn't.
That's what "patency" measures: is the treated vessel still open and working, without another procedure? Six months after treatment with Solaris DE, 92.7% were. The number that matters most comes from the randomized arm, where 80 fistula patients got either Solaris DE or a standard balloon: 92.0% patency against 65.9%. The 40 graft patients, treated single-arm, came in at 93.5%. Even on the tougher whole-circuit measure, the device led 81.3% to 65.9%. Safety held too, with 97.3% of patients free of safety events at 30 days.
Dr. Harduin told the audience the high patency "demonstrates a compelling treatment effect," one with the potential to "reduce the need for repeat intervention." For a dialysis patient, that's the whole point. Fewer failures, fewer procedures.
Built for the failure mode
Covered stents tend to fail at their edges, where the device ends and scar tissue narrows the vessel all over again. Solaris DE was engineered around that specific problem: a self-expanding nitinol frame, an electrospun PTFE membrane, and the drug sirolimus released right at the uncovered edges. Put the drug where the failure happens. Six months in, the data says the idea is working.
The regulatory picture
The FDA granted Solaris DE Breakthrough Device Designation back in May, the agency's fast lane for devices that could treat serious conditions more effectively than what exists. Alongside the CIRSE presentation, Brazil's regulator ANVISA approved a 40-patient expansion of the trial. The device is still investigational and isn't for sale anywhere yet, which is normal at this stage. The point is that the evidence is stacking up in the right order: designation, randomized data, expanded enrollment.
Our view
Dialysis access is a big, badly served market, and Solaris is in our portfolio because the team brought a specific engineering answer to its most stubborn failure mode, not a pitch about one. Randomized data is where clinical-stage companies either prove it or don't. A 26-point advantage over the standard of care, presented by the principal investigator on the field's biggest stage, is the kind of proof you can't manufacture. We'd rather show you readouts like this than adjectives.
Source: Solaris Endovascular press release · September 8, 2026 ↗
About Solaris Endovascular: a U.S.-based, growth-stage medical technology company developing next-generation endovascular covered stents for dialysis access dysfunction and peripheral artery disease.
Solaris DE is an investigational device and is not approved for commercial sale. Clinical figures are as reported by Solaris Endovascular in the source release above. This insight is provided for information purposes only and is not an offer to sell or a solicitation to buy securities, nor investment advice.