XVIVO says FDA accepts PMA filing for Heart Assist Transport System

By Public Technologies
  • Xvivo Perfusion filed a Premarket Approval application with the FDA for its XVIVO Heart Assist Transport System.
  • Submission is backed by clinical data from the PRESERVE IDE trial, which enrolled 141 patients at 14 US heart-transplant centers.
  • The device targets preservation and transport of extended-criteria donor hearts using hypothermic oxygenated perfusion.
  • FDA also authorized up to 120 patients in the PRESERVE Continued Access Protocol while the PMA review proceeds.


Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Xvivo Perfusion AB published the original content used to generate this news brief on September 28, 2026, and is solely responsible for the information contained therein.

Capital.com is an execution-only brokerage platform and the content provided on the Capital.com website is intended for informational purposes only and should not be regarded as an offer to sell or a solicitation of an offer to buy the products or securities to which it applies. No representation or warranty is given as to the accuracy or completeness of the information provided.

The information provided does not constitute investment advice nor take into account the individual financial circumstances or objectives of any investor. Any information that may be provided relating to past performance is not a reliable indicator of future results or performance.

To the extent permitted by law, in no event shall Capital.com (or any affiliate or employee) have any liability for any loss arising from the use of the information provided. Any person acting on the information does so entirely at their own risk.

Any information which could be construed as “investment research” has not been prepared in accordance with legal requirements designed to promote the independence of investment research and as such is considered to be a marketing communication.