Medtronic’s VenaSeal Closure System Evaluated in 24-Month Data From VLU Study

October 5, 2026—Medtronic announced the presentation of new findings for the company’s VenaSeal closure system for the treatment of chronic venous disease.

The 24-month results from the Venous Leg Ulcer (VLU) study, which is one of three separate studies making up the VenaSeal Spectrum Program, were presented at the annual VEINS conference held by the VIVA Foundation. VenaSeal is commercially available in 70 countries, including the United States and all European Union member countries, noted the press release.

According to the company, the presentation of the new evidence supporting the device coincides with the recent approval of coverage for VenaSeal by all major commercial payers in the United States The two events expand access to treatment for patients for chronic venous disease, from symptomatic venous insufficiency to advanced disease with active venous leg ulcers.

Medtronic reported that the prospective, single-arm VLU study evaluated VenaSeal treatment in 125 patients with active venous leg ulcers and advanced chronic venous disease (C6 disease). Patients were enrolled globally.

As outlined in Medtronic’s press release, key findings include:

• 88.1% ulcer healing rate through 24 months
• Median time to ulcer healing of 92 days
• 22.9% cumulative incidence of recurrence (ie, 77.1% freedom from ulcer recurrence) through 24 months after initial healing
• An average of 487 ulcer-free days after initial healing
• 78% anatomic closure through 24 months
• Symptoms and quality of life improved from baseline
• A low reintervention rate through 24 months

Manjit Gohel, MD, is Principal Investigator for the VenaSeal Spectrum Program.

“These rigorous clinical results show that the VenaSeal system works in the most challenging subset of patients with severe disease—healing ulcers, relieving symptoms, treating the underlying venous disease, and achieving durable results,” commented Dr. Gohel in Medtronic’s press release. “Based on these findings, it is evident that the VenaSeal system is an appropriate, safe, and effective treatment for venous leg ulcers, the most advanced phase of superficial venous disease.”

Medtronic advised that the new date add to the study’s 12-month data, which were presented at the Charing Cross International Symposium in April 2025.