Xvivo Perfusion Files US Premarket Approval Application for Donor Heart Preservation System

MT Newswires · 1d ago
05:59 AM EDT, 09/28/2026 (MT Newswires) -- Xvivo Perfusion (XVIVO.ST) submitted a premarket approval application for its donor heart preservation technology to the US Food and Drug Administration. The application for Xvivo Heart Assist Transport System is backed by clinical data from the Preserve Ide trial, with additional evidence from the Preserve Continued Access Protocol trial and clinical experience outside the US, the medical technology company said Monday.