Leading LVAD company in the State of Texas

Evaheart, Inc. ("EVI") is a medical device company based in the Texas Medical Center of Houston. EVI was established to gain regulatory approval and commercialize the EVAHEART®2 Left Ventricular Assist System in the North American market and start distribution in Europe. Under an FDA-approved IDE, a bridge-to-transplant (BTT) clinical trial of the EVAHEART®2 LVAS is currently ongoing in US.

 Aerial view of Texas Medical Center 

Aerial view of Texas Medical Center 

Our Mission

To return severe heart failure patients to their home with high quality of life.

What We've Achieved

  • Over 9-year durability testing with no mechanical failure.
  • Regulatory clearance granted (by PMDA) and now clinically used in Japan
  • Total 168 EVAHEART® LVAS have been implanted to-date (Oct-2017).
  • IDE (Investigational Device Exemption) approved by the FDA.
  • IDE clinical trial (BTT trial) in North America is underway.
  • New miniaturized pump and inflow cannula are implemented.
  • CE mark approval (C01 system), pending EVAHEART®2 (smaller controller and smaller pump with new inflow cannula) approval.