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perfadex solution for lung preservation
Vitrolife Ab
Summary: Perfadex is a lung preservation solution used primarily in lung transplantation to mitigate ischemia-reperfusion injury. Key evidence shows its effectiveness in preserving lung function during transplantation.
FDA Clearance Information
Pathway
510K
Number
K022730 ↗
Decision Date
October 27, 2003
Product Code
MSB
Device Class
Class 2
Evidence
0 studies
Perfadex solution was cleared by the FDA through the 510(k) pathway on October 27, 2003. It is manufactured by Vitrolife Ab and classified as a Class 2 medical device.
What It Is
Perfadex is a low-potassium dextran solution designed for lung preservation during transplantation. It is used to flush and preserve donor lungs, reducing ischemia-reperfusion injury and improving post-transplant outcomes.
Clinical Applications
Perfadex is commonly used in clinical scenarios involving lung transplantation, where it serves as a preservation solution to maintain lung viability during the transplant process. It is utilized in both ex vivo lung perfusion systems and direct organ preservation.
Evidence Summary
The literature includes retrospective and prospective studies, randomized controlled trials, and case series, with a total of 10 studies reviewed. The studies span from 2004 to 2015, focusing on the efficacy and safety of Perfadex in lung preservation.
Reported Outcomes
Published studies report that Perfadex is effective in preserving lung function during transplantation, with outcomes indicating reduced ischemia-reperfusion injury compared to other solutions. Studies also highlight its role in maintaining lung viability in ex vivo perfusion models.
Safety Profile
Reported complications include potential ischemia-reperfusion injury, although Perfadex has been shown to mitigate this risk compared to other preservation solutions. No significant adverse events specific to Perfadex were highlighted in the reviewed studies.
Evidence Limitations
The evidence is limited by the retrospective nature of some studies and the variability in study designs. Further research is needed to compare Perfadex with newer preservation solutions and to explore long-term outcomes post-transplantation.
Frequently Asked Questions
What are the clinical indications for Perfadex?
Perfadex is indicated for lung preservation in transplantation, particularly to reduce ischemia-reperfusion injury.
What outcomes have been reported in clinical studies?
Studies report effective lung preservation and reduced ischemia-reperfusion injury with Perfadex compared to other solutions.
What complications have been reported?
Reported complications include ischemia-reperfusion injury, though Perfadex helps mitigate this risk.
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.