ReliantHeart expands CE Mark for HeartAssist5 ventricular assist device
ReliantHeart wins European regulatory approval for its HeartAssist5 ventricular assist device for treating patients with end-stage heart failure.
ReliantHeart this week won expanded CE Mark approval in Europe for its ventricular assist device, which the company calls "the only remotely monitored VAD in the world."
The HeartAssist5 system originally won European approval under MicroMed Technology Inc. and was available commercially in 2009, according to a press release. ReliantHeart won the MicroMed's assets through "the completion of a court approved transaction," the company said.