Abiomed receives PMA (premarket approval) supplement:
This article was originally published in Clinica
Executive Summary
The FDA has given Abiomed a premarket approval supplement for four of its new atrial cannulae featured in the BVS artificial heart system. The cardiac assist device gives temporary circulatory support to failed transplant patients, those who fail to come off cardiopulmonary bypass after heart surgery and those who require right heart support after insertion of an implantable left ventricular assist device.