|New Medtronic Data Demonstrate Clinical and Quality of Life Benefits for VenaSeal Closure System in Venous Reflux Disease Patients|
Three-Year VeClose Trial and One-Year WAVES Study Data Presented at Charing Cross
DUBLIN and LONDON - April 25, 2017 - Medtronic plc (NYSE: MDT) today announced three-year outcomes from the VeClose U.S. pivotal clinical trial and one-year data from the WAVES study. Both results were presented by Kathleen Gibson, M.D., of Lake Washington Vascular in Bellevue, Wash., at the 2017 Charing Cross Symposium in London. The new data demonstrate the clinical and quality of life benefits of the Medtronic VenaSeal(TM) closure system in treating patients with venous reflux disease.
Three-Year Data from VeClose Trial
At three-years, the complete closure of the GSV was achieved in 94.4 percent of patients treated with VenaSeal compared to 91.9 percent of patients treated with ClosureFast - showing both the continued long-term, non-inferior outcomes (p=0.005) and the durability of the treatment.
Additionally, 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 scores. In all three assessments, patients treated with either VenaSeal or ClosureFast reflected statistically significant improvement from baseline.
"The three-year outcomes for this randomized trial reinforce the consistent clinical performance of VenaSeal and ClosureFast," said Dr. Gibson. "These long-term VenaSeal data along with post-market WAVES study results continue to build on the prior findings for this innovative treatment option for venous reflux disease, demonstrating safety, effectiveness, and quality of life."
One-Year WAVES Study Data Presented for the First Time
Key findings from the WAVES study are summarized as follows:
"The data presented at Charing Cross further demonstrate the VenaSeal closure system as a safe and effective therapy for treating venous reflux disease," said Sandra Lesenfants, vice president and general manager of the endoVenous business, which is part of the Cardiac and Vascular Group at Medtronic. "Together with the clinical community, we look forward to continuing our investment in clinical research to support the use of this innovative, minimally invasive treatment for venous reflux disease."
About VenaSeal Closure System
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.