Five-Year Outcomes Support Medtronic's VenaSeal Closure System in Patients With Chronic Venous Disease
April 17, 2019—The 5-year outcomes from the VeClose Extension study were presented by Nick Morrison, MD, at the Charing Cross Symposium, held April 15–18 in London, United Kingdom. The new data demonstrate durable and consistent long-term outcomes of the VenaSeal closure system (Medtronic) in treating patients with chronic venous disease, announced Medtronic.
This follow-on study, which sought to evaluate long-term outcomes with the VenaSeal closure system, found that the aggregate complete closure rate of the great saphenous vein was 94.6% (53/56) in the VenaSeal patients who completed 5-year postprocedure follow-up. These patients included 47 randomized patients and nine roll-in patients.
Medtronic advised that patients in the original VeClose study were randomized to receive treatment with VenaSeal or the ClosureFast radiofrequency ablation (RFA) device (Medtronic). The investigators found that vein closure estimates were 91.4% for VenaSeal and 85.2% for RFA, demonstrating continued noninferiority of VenaSeal to RFA through 5 years. Estimates were by Kaplan-Meier analysis of the randomized cohorts to evaluate success over the life of the study through 5 years
As summarized by the company, patient improvement was rated on three assessments: Venous Clinical Severity Score, Aberdeen Varicose Vein Questionnaire, and EuroQoL five dimensions.
By all measurements, patients sustained or maintained improvements in quality of life after treatment with either VenaSeal or RFA. These first prospective 5-year data for VenaSeal demonstrate a strong clinical portfolio with sustained long-term outcomes.
Dr. Morrison commented in Medtronic's announcement, "The 5-year data support the safety, effectiveness, and quality-of-life–enhancing capability of both VenaSeal and ClosureFast in treating patients with chronic venous disease. Furthermore, the data demonstrate long-term, strong, and consistent outcomes. The industry will benefit from long-term data like this so that physicians and patients can be confident in their treatment choice."
Medtronic advised that the original VeClose study was a United States pivotal clinical trial that was conducted under an investigational device exemption as a prospective, randomized controlled trial that compared the safety and effectiveness of the VenaSeal closure system to RFA. VeClose study outcomes have been previously reported, and the study has since concluded.