BioSphere's Sequitor guidewire
This article was originally published in Clinica
Executive Summary
BioSphere Medical has received US FDA 510(k) clearance to sell its Sequitor steerable guidewire, the newest addition to its line of embolic delivery products. The device is designed to facilitate the placement of catheters within the peripheral vasculature for various interventional procedures, including uterine fibroid embolisation and embolisation of hypervascularised tumours, such as liver tumours. The Rockland, Massachusetts firm expects to start shipping Sequitor in the US next month, when it also anticipates the product will be CE-marked and launched in Europe. BioSphere's principal focus is on uterine fibroid embolisation using its bioengineered microsphere technology.