Medtronic files first DES (drug-eluting stent) PMA (Pre-market Approval) module:
This article was originally published in Clinica
Executive Summary
Medtronic has initiated efforts to take its Endeavor drug-eluting stent (DES) to the US market, after submitting to the FDA the first of four premarket approval (PMA) modules for the device. The ABT-578-coated stent, which is used to prevent coronary restenosis, made its market debut in Europe in August this year. The company said it planned to file the remaining PMA modules over the coming year, during which time it should have obtained the necessary data to support the product. While several companies sell DESs in Europe, only Boston Scientific and Johnson & Johnson have gained approval to sell such devices in the US.