First Patient Receives HeartAssist5® VAD Following CE Mark Approval
Houston, Texas, June 6, 2014. Privately-held ReliantHeart, a leading innovator in mechanical circulatory support therapies, today announced the first advanced stage heart failure patient received its next generation HeartAssist5® Ventricular Assist Device (VAD) since the company earned CE Mark approval for design enhancements just weeks ago. Cardiologists at the Deutsches Herzzentrum Berlin (DHZB – German Heart Institute) in Germany performed the life-saving procedure.
“The quick acceptance and use of our support device following CE Mark approval speaks volumes and sets us on our path to restoring health and extending the life of millions of people suffering from heart failure worldwide,” said Rodger Ford, president and CEO of ReliantHeart.
Implanted above the diaphragm and weighing just 3.3 ounces, this next generation ventricular assist device offers natural human pulse circulation support to the weakened heart.
Unique to the HeartAssist5® is its 24/7 HeartAssistRemote™ Monitoring System which continuously receives and transmits patient data via vadlink.com to expert clinicians. Combined with a proprietary true-flow measurement system, these optimized device features allow for faster and more precise diagnosis of potential issues.
The HeartAssist5® is commercially available in Europe and is considered an Investigational Device in the USA by the Food and Drug Administration (FDA). The US clinical trial is expected to start in late 2014.
About ReliantHeart, Inc.
ReliantHeart, Inc. is a leading innovator in mechanical circulatory support therapies for advanced stage heart failure. The company manufactures the HeartAssist5®, a next generation ventricular assist device (VAD) which has been granted CE Mark approval for commercial sale in Europe. The HeartAssist5® is an implantable, electric pump designed for use in patients requiring ventricular support due to end stage heart failure and is the world’s only fully remotely monitored VAD.