|Medtronic VenaSeal Closure System Demonstrates Long-Term Durability and Improved Quality of Life in Patients with Venous Reflux Disease|
Medtronic Unveils Data for VenaSeal Closure System at Charing Cross and the International Vein Congress
DUBLIN - April 28, 2016 - This week at the 2016 Charing Cross Symposium in London and the International Vein Congress in Miami, Medtronic plc (NYSE: MDT) unveiled clinical data for the VenaSeal(TM) closure system demonstrating consistent long-term durability and improved quality of life in patients with venous reflux disease. The new data presented included two-year outcomes from the VeClose pivotal clinical study, with two additional subanalyses evaluating quality of life and physician ease-of-use; and three-year results from the European Sapheon Closure System Observational ProspectivE (eSCOPE) study.
VenaSeal is a non-tumescent, non-thermal, non-sclerosant procedure that uses a proprietary medical adhesive to close superficial veins of the lower extremities, such as the great saphenous vein (GSV), in patients with symptomatic venous reflux.
"As shown by our unmatched body of Level 1 evidence in the venous industry, Medtronic has demonstrated its deep-rooted commitment to providing clinically-proven and patient friendly treatment options for patients with chronic venous insufficiency," said Sandra Lesenfants, vice president and general manager of the endoVenous business in Medtronic's Aortic and Peripheral Vascular division. "We're enthusiastic about the unveiling of such strong datasets, and we look forward to continuing to build upon this clinical program."
VenaSeal Two-Year Closure Rates Meet Gold Standard in Level 1 VeClose Study
At two-years, the complete closure of the GSV was achieved in 94.3 percent of patients treated with VenaSeal compared to 94.0 percent of patients treated with ClosureFast(TM), showing continued, similar long-term non-inferiority outcomes (p=0.0075).
The VeClose U.S. pivotal clinical study is a prospective, randomized, controlled, non-inferiority study that compares the safety and effectiveness of the VenaSeal closure system to the gold standard ClosureFast endovenous radiofrequency ablation procedure. Two hundred and forty-two patients with symptomatic refluxing great saphenous veins were enrolled in the trial. Patients were randomized to receive treatment with VenaSeal and treatment with ClosureFast.
Subanalysis Demonstrates Improved Quality of Life with VenaSeal
"This randomized trial demonstrates VenaSeal's ability to provide a safe and effective treatment for patients with varicose veins," said Dr. Kathleen Gibson. "With excellent outcomes at two years, VenaSeal offers patients an alternative treatment to traditional therapies for varicose veins, allowing a rapid recovery with minimal downtime and diminished post-procedure bruising."
VenaSeal Associated with Minimal Learning Curve
Three-month follow-up results show that 19 of the 20 patients returned for follow-up. The investigators achieved complete closure of the GSV in 100 percent of these follow-up patients, demonstrating comparable efficacy and safety outcomes to the randomized patients treated with VenaSeal (99%, n=103) and ClosureFast (95.4%, n=103).
"Despite having no prior physician experience with VenaSeal, these data demonstrated remarkable ease-of-use and a limited learning curve for first-time-users as compared to experienced users," said Nick Morrison, M.D., Morrison Vein Institute, Scottsdale, Ariz., and national principal investigator of the VeClose trial.
High Closure Rates with VenaSeal Consistent Out to Three Years in eSCOPE Study
eSCOPE is an international, multi-center, prospective, single arm, observational, post-market study designed to record the clinical outcomes of the CE (Conformité Européenne) Marked VenaSeal.
The VenaSeal system is currently available in the U.S., New Zealand, Chile, South Africa, Australia, Canada, Europe, United Arab Emirates, Hong Kong and Turkey. To learn more visit: www.medtronic.com/endovenous.
In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world.
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.
1 Proebstle, TM, Alm J, Dimitri S et al. The European multicenter cohort study on cyanoacrylate embolization of refluxing great saphenous veins. J Vasc Surg Venous and Lymphat Disord.