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 (GSV) was 94.6 percent (53/56) 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 (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 percent for VenaSeal and 85.2 percent for RFA, demonstrating continued non-inferiority of VenaSeal to RFA through five years.
Patient improvement was rated on three assessments: Venous Clinical Severity Score (VCSS), a clinical venous disease assessment; and the Aberdeen Varicose Vein Questionnaire (AVVQ) and EQ-5D - both of which provide patient-reported quality of life (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."
The original VeClose Study was a U.S. pivotal clinical trial that was conducted under an investigational device exemption (IDE) as a prospective, randomized, controlled trial comparing the safety and effectiveness of the VenaSeal Closure System to RFA. VeClose Study outcomes have been previously reported, and the study has since concluded.
"The Medtronic commitment to long-term clinical evidence and improving patient outcomes is underscored by the release of this five-year VeClose Extension Study data," said Sandra Lesenfants, vice president and general manager of the endoVenous business, which is part of the Aortic, Peripheral, and Venous division at Medtronic. "VenaSeal has already been used in more than 100,000 procedures and that number is growing daily. We want to continue to expand minimally invasive innovation to improve the quality of life for all patients with venous disease."