Evaheart, Inc. Email Format

Biotechnology ResearchTexas, United States11-50 Employees

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 Multi-Center Prospective Randomized Clinical Trial (COMPETENCE TRIAL) of the EVAHEART®2 LVAS is currently ongoing in US.

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 183 EVAHEART® LVAS have been implanted to-date (July-2018).
- 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.

"RESPECT PULSATILITY"

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