Vascular sealing device submitted for US approval:
This article was originally published in Clinica
Executive Summary
Vascular Solutions has submitted a premarket approval (PMA) application to the US FDA for its device for rapidly sealing puncture holes made in the arteries by catheterisation procedures. The Duett sealing device works by deploying a small balloon catheter through the existing catheter sheath to begin haemostasis. A procoagulant agent is then delivered directly to the puncture site, via a sidearm of the introducer sheath, to permanently seal the access site. The Minneapolis, Minnesota-based company said the new device would improve patient comfort and outcomes and lower overall treatment costs compared with the traditional compression closure methods.