Regulatory Approvals

European

CE Mark – Approval May 2014

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.
ReliantHeart aVAD (Ventricular Assist Device) gained CE Mark approved August 2, 2016, for use in patients requiring ventricular support due to end stage heart failure. The aVAD 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.

 

Remote Monitoring

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.

United States

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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