XVIVO says FDA accepts PMA filing for Heart Assist Transport System

• 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.

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