Vessel filter benefits outweigh risks, FDA panel decides
This article was originally published in Clinica
An FDA advisory panel has endorsed Medtronic's distal protection system as ready for marketing because it can greatly reduce the life-threatening complications that arise in treating saphenous vein graft disease. Meeting in Gaithersburg, Maryland, on February 5 the Circulatory Devices Advisory Committee agreed that despite a high malfunction rate, the benefits of the new system outweigh the risks. There was no formal vote because the company was only seeking premarket notification via a 510(k).