ReliantHeart said yesterday it won CE Mark approval in the European Union for its aVAD left ventricular assist device. The aVAD device is an axial flow LVAD that features remote monitoring and flow measurement, according to an MD+DI report. ReliantHeart said that manufacturing of the device is already underway, with 65 units slated to be […]
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.