Abbott files PMA (premarket approval) for StarClose vessel closing tech:
This article was originally published in Clinica
Executive Summary
Abbott Vascular has submitted to the US FDA a premarket approval (PMA) application for its StarClose vascular closure system, a next-generation device designed for the simple, quick and secure mechanical closure of femoral arteries following catheterisation procedures. StarClose works by delivering a flexible nitinol clip that mechanically binds the surface of the artery. The device differentiates itself from other products by leaving nothing behind in the artery that could cause potential blockages later, claims the Abbott Park, Illinois firm. StarClose, which is CE-marked for sale in Europe, was launched outside of the US in 2004.