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Medtronic VenaSeal Closure System Demonstrates Long-Term Durablity and Improved Quality of Life in Patients with Venous Reflux Disease

(GLOBE NEWSWIRE via COMTEX) -- 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 MDT, +1.50% 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

New two-year results from the VeClose trial were presented at Charing Cross by Raghu Kolluri, M.D., medical director of vascular medicine at Riverside Methodist Hospital in Columbus, Ohio, and by Kathleen Gibson, M.D., of Lake Washington Vascular in Seattle at the International Vein Congress.

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...


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