Evaheart, Inc.
www.evaheart-usa.comLEADING 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
Read moreLEADING 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
Read moreCountry
State
Texas
City (Headquarters)
Houston
Industry
Employees
11-50
Founded
2014
Estimated Revenue
$5,000,000 to $10,000,000
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