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perfadex plus
Xvivo Perfusion Ab
Summary: Perfadex Plus is a solution used in ex vivo lung perfusion (EVLP) to evaluate and preserve donor lungs. It is primarily used to improve lung transplant outcomes. Key evidence includes studies on its efficacy in lung preservation and potential to reduce graft injury.
FDA Clearance Information
Pathway
510K
Number
K170826 ↗
Decision Date
June 22, 2018
Product Code
KDN
Device Class
Class 2
Evidence
0 studies
Perfadex Plus was cleared by the FDA via the 510(k) pathway on June 22, 2018. It is manufactured by Xvivo Perfusion Ab and classified as a Class 2 device under product code KDN.
What It Is
Perfadex Plus is a perfusion solution designed for ex vivo lung perfusion (EVLP), a technique used to assess and preserve donor lungs before transplantation. It aims to improve lung function and viability by providing an optimal environment during the evaluation process.
Clinical Applications
Perfadex Plus is commonly used in scenarios involving lung transplantation, particularly for assessing and preserving lungs from donors. It is utilized in EVLP systems to enhance the quality and suitability of donor lungs for transplantation.
Evidence Summary
The literature includes seven studies, comprising randomized controlled trials and other study types, conducted between 2008 and 2020. These studies explore the efficacy and safety of Perfadex Plus in lung preservation and transplantation contexts.
Reported Outcomes
Published studies report that Perfadex Plus is effective in preserving lung function during ex vivo lung perfusion. It has been shown to potentially reduce graft injury and improve transplant outcomes. The solution's role in optimizing lung preservation is supported by experimental models and clinical trials.
Safety Profile
Reported complications include potential cold-induced injury mediated by chelatable iron, as observed in endothelial cells. However, no significant adverse events directly related to Perfadex Plus were highlighted in the reviewed studies.
Evidence Limitations
The evidence is limited by the small number of clinical trials and the reliance on animal models for some findings. Further research is needed to confirm long-term outcomes and safety in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Perfadex Plus?
Perfadex Plus is indicated for use in ex vivo lung perfusion to evaluate and preserve donor lungs for transplantation.
What outcomes have been reported in clinical studies?
Studies report improved lung preservation and reduced graft injury, enhancing transplant suitability and outcomes.
What complications have been reported?
Reported complications include potential cold-induced injury related to chelatable iron, but no significant adverse events specific to Perfadex Plus were noted.
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.