CE Mark – Approval May 2014
ReliantHeart Conquest Controller received full quality assurance approval for the design and manufacture of the GSM communications aspects of the remote monitoring according to Council Directive 1999/5/EC Annex V on radio equipment and telecommunications equipment as transposed into UK law by S.I. 2000 No. 730.
The HeartAssist5® is a device limited by Federal law to investigational use in the United States.
IDE Clinical Trial – Approval August 2014
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.
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