đź“Š Evidence-Based Reference
perfadex solution for organ preservation
Vitrolife Sweden Ab
Summary: Perfadex solution is used for organ preservation, primarily in lung transplantation. Key evidence suggests its efficacy in reducing ischemia-reperfusion injury.
FDA Clearance Information
Pathway
510K
Number
K000881 ↗
Decision Date
March 8, 2001
Product Code
MSB
Device Class
Class 2
Evidence
0 studies
Perfadex solution was cleared by the FDA via the 510(k) pathway on March 8, 2001. It is manufactured by Vitrolife Sweden Ab and classified as a Class 2 device.
What It Is
Perfadex solution is a preservation solution used in organ transplantation, particularly for lungs. It is designed to minimize ischemia-reperfusion injury during the preservation period.
Clinical Applications
Perfadex is commonly used in clinical scenarios involving lung transplantation. It is utilized to flush and preserve donor lungs in ex vivo lung perfusion systems.
Evidence Summary
The literature includes 10 studies, comprising RCTs and other study types, conducted between 2004 and 2025. These studies evaluate the efficacy and safety of Perfadex in organ preservation.
Reported Outcomes
Published studies report that Perfadex solution effectively reduces ischemia-reperfusion injury in lung transplantation models. It is associated with improved mitochondrial protection in cardiac tissues and is commonly used in ex vivo lung perfusion systems.
Safety Profile
Reported complications include potential ischemia-reperfusion injury if not used correctly. However, the studies did not highlight significant adverse events directly attributable to Perfadex.
Evidence Limitations
The evidence is limited by the variability in study designs and the lack of large-scale, multicenter trials. Further research is needed to establish long-term outcomes and comparative effectiveness with other preservation solutions.
Frequently Asked Questions
What are the clinical indications for Perfadex solution?
Perfadex is indicated for use in organ preservation, particularly in lung transplantation to reduce ischemia-reperfusion injury.
What outcomes have been reported in clinical studies?
Studies report that Perfadex effectively reduces ischemia-reperfusion injury and improves mitochondrial protection in organ transplantation.
What complications have been reported?
Safety data indicate potential ischemia-reperfusion injury if not used correctly, but no significant adverse events were directly linked to Perfadex.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.