US green light for Medtronic cobalt stent:
This article was originally published in Clinica
Medtronic today (October 2 2003) received FDA approval to market its Driver coronary stent in the US. The premarket approval (PMA) covers use of the stent for improving coronary luminal diameter in patients with de novo or restenotic lesions in vessels with diameters of 3-4mm, and less than or equal to 30mm in length. It is made of a cobalt-based alloy, allowing thinner struts than steel equivalents. The Driver stent is already in use in Europe where it has 29% market share for vessels 3mm and above, making it the leading cobalt alloy stent in Europe, according to Medtronic.