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.
A 2012 amendment to the CE Mark label granted around-the-clock remote monitoring via the HeartAssist5 Conquest Controller, a wearable system that collects and transmits patient data to healthcare providers, according to the press release.
HeartAssist5 has E.U. approval as a bridge to transplant or destination therapy in patients awaiting donor hearts or those who are not candidates for transplants. Reliant Heart is currently seeking FDA Investigational Device Exemption to perform U.S. clinical trials in advance of an application for market approval.