Evaheart, Inc.
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- 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® 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® LVAS is currently ongoing in the USA. What We've Achieved: - Over 7-year durability testing with no mechanical failure - Preclinical animal testing completed - Regulatory clearance granted (by PMDA) and now clinical use in Japan - Total 119 EVAHEART® LVASs have been implanted to-date. - CE mark approval (C01 system), C02 (smaller controller) approval. - IDE (Investigation device exemption) approved by the FDA - IDE clinical trial (BTT trial) in North America is underway. - New external controller and inflow cannula are implemented *IDE sponsorship was transferred from EMUSA (Evaheart Medical USA) to EVI (Evaheart, Inc, Houston) (c) Christian Schmidt-Mewes
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Headquarters:6655 Travis Street , Houston, Texas, United States
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Phone Number: +1 713-520-7979
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Employees:6
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Revenue:$1 - 10M
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Legal Name:Evaheart, Inc.
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Evaheart, Inc.'s Social Media
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| NAICS Code: 999990 |
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Frequently Asked Questions regarding Evaheart, Inc.
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Where are Evaheart, Inc.'s Headquarters?
Evaheart, Inc.'s Headquarters are in 6655 Travis Street ,Houston,Texas,United States
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What is Evaheart, Inc.'s phone number?
Evaheart, Inc.'s phone number is +1 713-520-7979
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What is Evaheart, Inc.'s Revenue?
Evaheart, Inc.'s revenue is $1 - 10M
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What is Evaheart, Inc.'s NAICS code?
Evaheart, Inc.'s NAICS code is 999990
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How many employees are working in Evaheart, Inc.
Evaheart, Inc. has 6 employees
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What is Evaheart, Inc.'s Industry?
Evaheart, Inc. is in the industry of Medical Devices
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Who is Evaheart, Inc.'s Investment And Business Development Manager?
Evaheart, Inc.'s Investment And Business Development Manager is Han Zhang
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Who is Evaheart, Inc.'s Lead Clinical Support Specialist?
Evaheart, Inc.'s Lead Clinical Support Specialist is Brian Kelly