Cook first to file paclitaxel-eluting stent:
This article was originally published in Clinica
Cook has become the first company to submit a marketing application for a paclitaxel-eluting coronary stent anywhere in the world, after filing the device for European CE mark approval. The filing was based on the results of Cook's European-based ELUTES clinical trial, which revealed a binary restenosis rate of just 3.1% due to paclitaxel's cytostatic mechanism of action in inhibiting neointimal hyperplasia. "Cook could begin selling its first drug-eluting coronary stents in Europe during the second quarter of this year," predicted Kem Hawkins, the Bloomington, Indiana firm's president.