ReliantHeart

ReliantHeart has developed two CE Mark-approved left ventricular assist devices—HeartAssist5 and aVAD—for advanced heart failure. HeartAssist5 was first approved in Europe under MicroMed Cardiovascular and remains unique as the only remotely monitored VAD. The aVAD, featuring active magnetic stabilization and improved efficiency, received CE Mark approval in August 2016. In the US, an IDE clinical trial began on HeartAssist5 with first implantation at University of Chicago Medicine in March 2015. No recent pivotal or commercial-stage US approvals are reported.[1][4] Clinical results have not been detailed publicly beyond regulatory milestones.