Startups
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"
(c) Christian Schmidt-Mewes
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"
(c) Christian Schmidt-Mewes
Overview
Location
United States, Texas, Houston
Employees
11-50
Founded date
2014
FAQ about Evaheart, Inc.
When was Evaheart, Inc. founded?
Evaheart, Inc. was founded in 2014.
Is Evaheart, Inc. still active?
Yes, Evaheart, Inc. is active.