SVG (saphenous vein graft) protection device edges closer in Europe:
This article was originally published in Clinica
Executive Summary
Kensey Nash has received a recommendation from the European regulatory authority, TUV Rheinland, for CE-mark approval of its TriActiv balloon protected flush extraction system (see Clinica 978, p 16). The device, which is designed to prevent heart attacks during the treatment of bypass surgery patients with blocked saphenous vein grafts (SVG), has been shown to reduce complication rates from around 15-20% to just 6.9%, according to clinical trial data, says the Exton, Philadelphia firm.