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.
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.