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Corvion Receives Breakthrough Device Designation from FDA


Corvion Receives Breakthrough Device Designation from FDA
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WEBSTER, Texas, Dec. 16, 2020 /PRNewswire/ Corvion – developer of fully implanted mechanical circulatory support devices – announced today that it has received Breakthrough Device Designation for its fully implanted Left Ventricular Assist Device (LVAD) from the FDA.  The designation will allow the company to interact with the FDA s experts to efficiently address topics as they arise during product development and testing as well as result in prioritized review of an eventual PMA submission.
This Breakthrough Device Designation is a significant milestone for our company.  In the race to develop the world s first FDA approved fully implanted LVAD, this is a critical step forward.  While others have received the same designation for their proposed fully implanted systems, we are confident no other company has the potential to revolutionize th ....

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EverHeart Systems Announces Corporate Name Change to Corvion, Inc.


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WEBSTER, Texas, Dec. 10, 2020 /PRNewswire/  EverHeart Systems – developer of fully implanted mechanical circulatory support devices – announced today that it has changed its corporate name to Corvion, Inc. The name change has been chosen to further differentiate the Company s products and mission from others in the mechanical circulatory assist device field and better reflects the company s focus on high efficiency and wireless solutions for patients needing cardiac support.
The new corporate name – Corvion, Inc. – allows us to emphasize our world class pump efficiency and robust wireless charging technology that we believe will drive a new era in the use Left Ventricular Assist Devices (LVADs).  Patients will no longer be tethered to their controller and batteries, which limits their quality of life in so many ways. Decades have gone by with no viable fully implanted LVAD. We think it s time for a radical change, com ....

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