XVIVO Confirms FDA Receipt of PMA Application for Heart Assist Transport System
核心洞察
XVIVO Perfusion AB (搜索) announced the FDA has received its Premarket Approval application for the XVIVO Heart Assist Transport System (搜索).
The filing is supported by the PRESERVE IDE trial, which enrolled 141 patients at 14 US heart transplant (搜索) centers.
The device preserves extended-criteria donor hearts, including DCD and DBD grafts, using Hypothermic Oxygenated Perfusion.
XVIVO Perfusion AB (搜索) said the US Food and Drug Administration (搜索) has received its Premarket Approval (PMA) application for the XVIVO Heart Assist Transport System (搜索). The filing is supported by clinical data from the PRESERVE IDE trial, plus additional evidence from the PRESERVE Continued Access Protocol (CAP) trial and clinical experience outside the United States. The device remains investigational in the US and is not commercially available there.
The PRESERVE IDE trial enrolled 141 patients across 14 leading US heart transplant (搜索) centers. It evaluated the safety and effectiveness of the system for preservation and transport of extended-criteria donor hearts for transplantation into adult recipients, including donation after circulatory death (DCD) hearts and donation after brain death (DBD) hearts meeting specified extended donor criteria such as anticipated cross-clamp times and defined donor risk factors. The system is designed to preserve donor hearts using Hypothermic Oxygenated Perfusion (HOPE).
The CAP trial was established to allow continued clinical use of XVIVO's heart technology while one-year follow-up data from the IDE trial was analyzed, with FDA authorizing enrollment of up to 120 patients so participating transplant centers could keep using the technology during PMA review. The submission follows recent CE certification of the XVIVO Heart Assist Transport system (搜索) in Europe.
Source: XVIVO Announces FDA Receipt of PMA Application for The XVIVO Heart Assist Transport System