đź“Š Evidence-Based Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- For the preservation of donor lungs intended for transplantation.
- For flushing and maintaining isolated lungs during the lung-transplant preservation process.
Clinical Applications
- Antegrade flushing of donor lungs during organ recovery.
- Preservation of donor lungs during transport before transplantation.
- Storage of isolated donor lungs before implantation in the recipient.
- Use with lung-preservation workflows, including compatible ex vivo lung perfusion systems, according to the system and solution labeling.
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.
Practical Considerations
- Perfadex is intended for use by trained transplant or organ-recovery teams and is not administered directly to patients as an intravenous medication.
- Use the solution according to its labeling, including preparation, temperature, sterility, storage, and expiration requirements.
- Compatibility with tubing, reservoirs, pumps, and ex vivo lung perfusion equipment should be confirmed before use.
- The product is not an implantable device and does not have an MRI safety classification relevant to an implanted patient.
- Clinical decisions about donor-organ suitability, preservation time, and transplantation remain the responsibility of the transplant team.
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.