Cook starts clinical trial of Logic stent:
This article was originally published in Clinica
Cook is to begin a multicentre clinical trial of its Logic coronary stent, under an investigational device exemption from the US FDA. The trial will include 400 patients with de novo lesions and 300 patients with acute and threatened vessel closure. The Logic stent, which consists of a slotted tubular design, is premounted on a 135cm balloon catheter that is compatible with a 0.014 inch guidewire. It is available in lengths of 10mm and 15mm. Results from the trial will form the basis of a PMA application to the FDA, says the Bloomington, Indiana company.