ReliantHeart’s world headquarters and its EN ISO 13485:2003/AC:2007 certified manufacturing facility is located in Houston, Texas. ReliantHeart has an International Office located in Uden, Netherlands.
IDE Clinical Trial – United States
ReliantHeart Inc. has been granted approval from the U.S. Food and Drug Administration Center for Devices and Radiological Health (FDA/CDRH) to conduct an Investigational Device Exemption (IDE) Clinical Trial on the HeartAssist5® Ventricular Assist Device System. The trial will be a prospective, 1:1 randomized, multicenter, clinical trial to evaluate the safety and efficacy of 96 patients implanted with the ReliantHeart HeartAssist5® Ventricular Assist Device (VAD) System compared to 96 patients implanted with either a Thoratec HeartMate II® LVAD or HeartWare HVAD for left ventricular support while awaiting cardiac transplantation. The trial is expected to run through 2017.
The HeartAssist5® is a device limited by Federal law to investigational use in the United States. The aVAD® is in preclinical testing.
CE Mark – Europe
ReliantHeart HeartAssist5® Ventricular Assist Device is CE Mark approved for use in patients requiring ventricular support due to end stage heart failure. The HeartAssist5® is approved for bridge to transplant (BTT – short term use) patients awaiting cardiac transplantation and for destination therapy (DT – long term use) patients who are not candidates for cardiac transplantation.