510(k) for IntraTherapeutics' nitinol stent:
This article was originally published in Clinica
Executive Summary
IntraTherapeutics' has received 510(k) market clearance in the US for its Intracoil self-expanding nitinol stent for treating malignant bronchial occlusions. The device, formerly known as VascuCoil, was acquired by the St Paul, Minnesota-based company from Medtronic Instent in November last year. It is available outside the US for use in superficial femoral and popliteal arteries of the leg.