Medtronic announces 5-year outcomes from VeClose Extension Study
Medtronic announced five-year outcomes from the VeClose Extension Study. Nick Morrison, M.D., Center for Vein Restoration, Mesa, AZ, presented at the 2019 Charing Cross Symposium in London. The new data demonstrate durable and consistent long-term outcomes of the Medtronic VenaSeal Closure System in treating patients with chronic venous disease. The VeClose Extension Study is a follow-on study with the purpose of evaluating long-term outcomes at five years post-treatment with the VenaSeal Closure System. The aggregate complete closure rate of the great saphenous vein, or GSV, was 94.6% in the VenaSeal subjects who completed five-year follow-up, including 47 randomized subjects and nine roll-in subjects. In the original VeClose Study, patients were randomized to receive treatment with VenaSeal or the Medtronic ClosureFast radiofrequency ablation, or RFA, device. By Kaplan-Meier analysis of the randomized cohorts to evaluate success over the life of the study through five years, vein closure estimates were 91.4% for VenaSeal and 85.2% for RFA, demonstrating continued non-inferiority of VenaSeal to RFA through five years. Patient improvement was rated on three assessments: Venous Clinical Severity Score, or VCSS, a clinical venous disease assessment; and the Aberdeen Varicose Vein Questionnaire, or AVVQ, and EQ-5D - both of which provide patient-reported quality of life, or QoL, outcomes. By all measurements, subjects sustained or maintained improvements in QoL after treatment with either VenaSeal or RFA. These first prospective five-year data for VenaSeal demonstrate a strong clinical portfolio with sustained long-term outcomes. "The five-year data support the safety, effectiveness, and quality of life-enhancing capability of both VenaSeal and ClosureFast in treating patients with chronic venous disease," said Dr. Morrison. "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."