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Corvion Receives Breakthrough Device Designation from FDA

WEBSTER, TexasDec. 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 the LVAD field in the same way we can.  Ultra low pump power consumption, safe implantable grade batteries, single external component wireless charging, enhanced pulsatility, and reduced blood trauma are just some of the factors that will differentiate us from competitors in the race, both large and small,” commented Greg S. Aber, CEO of Corvion.

“Our system’s development was started after commercially available devices were clinically used for years with major adverse events identified as infection, thromboembolic events, and bleeding.  We focused on addressing all of these issues using a set of breakthrough technologies that include a high-efficiency LVAD and an innovative transcutaneous energy transfer (TET) system.  The breakthrough designation is undoubtedly an important milestone and will be of significant value on our quest to improve LVAD patients’ quality of life,” said Dr. Luiz Sampaio, Director of Medical Affairs for Corvion.

The company intends to begin discussions with FDA in early 2021 and will benefit greatly from the FDA’s feedback.  The company welcomes the opportunity to share data and results with FDA to highlight the key differences and advantages of the Corvion LVAD.

About Corvion:

Corvion (www.corvion.com) is a pre-clinical stage medical device company focused on bringing fully implanted heart assist technology to the worldwide market for mechanical circulatory support.  By developing a highly efficient implantable rotary blood pump (3X more efficient than competitors) coupled with a robust and flexible transcutaneous (through the skin) charging technology, the company aims to dramatically improve patient outcomes and quality of life.

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https://www.prnewswire.com/news-releases/corvion-receives-breakthrough-device-designation-from-fda-301194444.html

EverHeart Systems Announces Corporate Name Change to Corvion

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,” commented Greg S. Aber, CEO of Corvion, Inc.

The new name is effective immediately and will be implemented across the company’s products and presentations throughout next year.

About Corvion:
Corvion (www.corvion.com) is a pre-clinical stage medical device company focused on bringing fully implanted heart assist technology to the worldwide market for mechanical circulatory support.  By developing a highly efficient implantable rotary blood pump (3X more efficient than competitors) coupled with a robust and flexible transcutaneous (through the skin) charging technology, the company aims to dramatically improve patient outcomes and quality of life.

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https://www.prnewswire.com/news-releases/everheart-systems-announces-corporate-name-change-to-corvion-inc-301190705.html?tc=eml_cleartime