FDA approval for Medtronic tissue heart valve:
This article was originally published in Clinica
Executive Summary
The US FDA has granted marketing approval for Medtronic's Mosaic porcine tissue heart valve. The device is a reduced-profile valve incorporating a flexible stent. It incorporates two Medtronic proprietary technologies: alpha-amino oleic acid treatment and the physiological fixation process. The company intends to delay launching the product until later this year due to "unprecedented demand" for its existing tissue valve range. Meantime it is increasing valve production to meet demand.