Cook gets US nod for pivotal PATENCY trial:
This article was originally published in Clinica
The US FDA has conditionally approved Cook's pivotal trial of its paclitaxel- eluting coronary stent for combating restenosis. PATENCY study, which will begin enrolling 200 patients at 20 sites immediately, is expected to keep Cook on track to launch its Logic PTX drug-eluting stent in the US next year, says the Bloomington, Indiana firm. In a separate announcement, Cook said it had gained US go-ahead to enrol 100 patients at 10 institutions in a randomised pilot study to assess its device as a treatment for in-stent restenosis.