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Medtronic presents results of VeClose pivotal study

Irish medical technology firm Medtronic has presented the twelve-month results of the VeClose pivotal study, which showed durability of its VenaSeal closure system.

According to the firm, the study demonstrated the safety and effectiveness of the VenaSeal closure system to treat incompetent greater saphenous veins with a 96.8% closure rate.

VenaSeal is said to use an advanced medical adhesive to close the diseased vein in patients with symptomatic venous reflux disease.

Medtronic aortic and peripheral vascular medical director Dr Mark Turco said: "The 12 month results of the VeClose trial demonstrates the durability of the system.

"This, combined with the improved patient comfort and reduced recovery times of the VenaSeal closure system, makes this a clinically-proven, patient-friendly treatment option for patients."

The VeClose US pivotal clinical trial is a prospective, randomized, controlled and non-inferiority study that compared the safety and effectiveness of the VenaSeal closure system to that of the ClosureFast endovenous radiofrequency ablation catheter.

The study included 250 patients with symptomatic refluxing great saphenous veins, of which 108 were randomized to receive treatment with the VenaSeal closure system and 114 with the ClosureFast catheter.

VenaSeal has already received approval in Australia, New Zealand, Canada, Europe, Hong Kong, and the US.