Medtronic’s VenaSeal shows high ulcer healing rates

IRELAND – Medtronic has announced encouraging outcomes from its Spectrum Venous Leg Ulcer (VLU) study, highlighting the efficacy of the VenaSeal closure system in treating advanced superficial venous insufficiency (SVI).

The single-arm study focused on patients with active venous leg ulcers (classified as CEAP C6), assessing the time to ulcer healing as the primary endpoint and vein closure over 12 months as a secondary endpoint. ​

Key findings from the study include: ​

• An 81.3% ulcer healing rate at one year
• An 82.7% anatomic closure rate at one year
• 83% freedom from ulcer recurrence at one year post-healing​

These results suggest that VenaSeal is effective even in patients with long-standing ulcers, with the median ulcer age being 169 days and the longest recorded at over 18 years. ​

Safety outcomes were consistent with existing literature, reporting low rates of hypersensitivity (0.8%), phlebitis (8.8%), granuloma (1.6%), and ablation-related thrombus extension (2.4%).

No device- or procedure-related deaths were observed, though eight serious adverse events were noted, including infections and superficial vein thromboses. ​

Dr. Manjit Gohel, a global principal investigator for the VenaSeal Spectrum Program, emphasized the significance of these findings, stating that the data provides strong evidence for VenaSeal’s role in managing patients with advanced venous disease. ​

The VenaSeal closure system is currently available in 70 countries, including the United States and European Union member states.

Medtronic’s Spectrum Program continues to expand the clinical evidence supporting VenaSeal’s use across the spectrum of superficial venous disease.