Among venous disease patients, those with active venous leg ulcers (C6 disease) are routinely left out of device trials, which makes the 24-month Spectrum study data presented at The VEINS 2026 in Las Vegas worth attention: 88.1% of 125 patients treated with VenaSeal cyanoacrylate closure healed their ulcers, with a median time to healing of 92 days. Recurrence through 24 months was 22.9%, and patients averaged roughly 487 ulcer-free days over the study period. Those numbers matter because most cyanoacrylate closure evidence has been confined to C2-C5 disease, and this prospective, 17-site observational study treated a population that standard trials exclude.
Two other late-breaking datasets rounded out the conference. The BERG02 study reported interim 6-month results for the VEnice percutaneous ligation device, which received FDA 510(k) clearance in late September 2026. In 22 patients with symptomatic great saphenous vein incompetence, technical success was 100%, deployment took one to two minutes per clip, and no device-related serious adverse events occurred within 30 days. All 22 GSVs remained closed at one month, and preliminary 6-month data showed complete closure in the eight patients with GSV results available. Core-lab adjudication of those 6-month outcomes is still pending, so the durability picture is incomplete until 12-month follow-up is reported.
The third presentation covered 30-day data from a real-world post-market registry of Medtronic’s Abre venous stent, enrolling 151 patients across 15 sites in Europe and the United States. The cohort skewed toward nonthrombotic iliac vein lesions (74.3% of cases) and was nearly three-quarters female, with a mean age of 50.6 years. Zero stent fractures occurred, and target lesion revascularization was needed in only one patient (0.7%) through 30 days. Patients with larger stent diameters (18-20 mm) reported more immediate post-procedure pain, but that difference resolved by day 30. The registry is designed for five years of follow-up, so the 30-day safety snapshot is a starting point rather than a conclusion.
Across all three studies, the Spectrum 24-month data carry the most immediate clinical weight: the 92-day median healing time in an ulcer population routinely excluded from research gives physicians a concrete durability benchmark to set against compression therapy alone, and the 22.9% recurrence rate frames how often re-intervention will likely be needed over two years.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
