Corvion announced that it received FDA breakthrough device designation for its left ventricular assist device (LVAD).
Webster, Texas-based Corvion said in a news release that the breakthrough nod for the fully implanted LVAD device allows the company to move forward with the FDA in addressing topics that arise during development and testing ahead of an eventual pre-market approval submission.
The company plans to begin discussions with the FDA over the LVAD device in early 2021, with the intent to share data and results to highlight what it touts as key differences and advantages with its system.
In developing its LVAD system, Corvion focused on addressing issues such as infection, thromboembolic events and bleeding by using breakthrough technologies including a high-efficiency LVAD and a transcutaneous energy transfer system, according to its director of medical affairs Dr. Luiz Sampaio.
“In the race to develop the world’s first FDA approved fully implanted LVAD, this is a critical step forward,” Corvion CEO Greg Aber said in the release. “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.”