Corvion Receives Breakthrough Device Designation from FDA
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 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.
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.
SOURCE Corvion, Inc.