Medtronic’s VenaSeal Evaluated in Spectrum Venous Leg Ulcer Study

April 24, 2025—Medtronic announced the primary and secondary outcomes of the VenaSeal Spectrum Venous Leg Ulcer study.

According to the company, the single-arm study prospectively assessed Medtronic’s VenaSeal closure system in patients with an active venous leg ulcer (classified as C6). The primary endpoint was time to ulcer healing after treatment with VenaSeal. The secondary endpoint was vein closure through 12 months.

The podium-first presentation of the results was delivered at the Charing Cross International Symposium 2025, held April 23-25 in London, United Kingdom.

The Principal Investigator of the VenaSeal Spectrum Program is Professor Manj Gohel, MD, Consultant Vascular Surgeon at Cambridge University Hospitals in Cambridge, United Kingdom, and honorary senior lecturer at Imperial College in London, United Kingdom.

“This rigorous clinical data demonstrates that VenaSeal delivers outstanding ulcer healing rates in a challenging subset of patients with advanced superficial venous disease,” commented Prof. Gohel in Medtronic’s press release. “The evidence should give physicians confidence that VenaSeal is an effective, safe, and appropriate treatment for a range of patients experiencing superficial venous insufficiency.”

As summarized in the Medtronic press release, VenaSeal delivered an ulcer healing rate of 81.3% and an anatomic closure rate of 82.7% at 1 year. The freedom from ulcer recurrence was 83% at 1 year after healing occurred.

The median ulcer age in the study was 169 days, with a maximum ulcer age of 6,816 days (18 years and 8 months), which demonstrated that VenaSeal can heal even the most chronic and long-standing ulcers, noted the company.

Medtronic advised that the safety events were review by an independent committee. The study showed that VenaSeal’s system-specific safety events were consistent with prospective literature. Events included hypersensitivity to VenaSeal (0.8%), phlebitis (8.8%), granuloma (1.6%), and ablation-related thrombus extension (2.4%). There were no device- or procedure-related deaths, reported the company.

The VenaSeal closure system is commercially available in 70 countries, including the United States and all European Union member countries, noted Medtronic.