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perfadex and perfadex with tham
Xvivo Perfusion Ab
Summary: Perfadex and Perfadex with Tham are solutions used in organ transplantation, specifically for lung preservation. They are utilized by transplant surgeons and medical teams in transplant centers.
FDA Clearance Information
Pathway
510K
Number
K091989 ↗
Decision Date
October 1, 2010
Product Code
KDN
Device Class
Class 2
Evidence
0 studies
Perfadex and Perfadex with Tham were cleared through the FDA 510(k) pathway on October 1, 2010. Manufactured by Xvivo Perfusion Ab, these devices are classified as Class 2 under product code KDN.
What It Is
Perfadex and Perfadex with Tham are preservation solutions used during lung transplantation procedures. They are designed to maintain the viability of donor lungs by reducing ischemic injury during transport and storage. The solutions work by providing an optimal environment that minimizes cellular damage and inflammation, thereby improving the success rates of lung transplants.
Clinical Applications
These solutions are primarily used in the setting of lung transplantation, a highly specialized procedure performed in transplant centers. They are essential during the ex vivo preservation phase, where donor lungs are kept viable before implantation into the recipient. The solutions are used by transplant surgeons and perfusionists to ensure the best possible outcomes for patients with end-stage lung disease requiring transplantation.
Indications for Use
Perfadex and Perfadex with Tham are indicated for use in the preservation of donor lungs intended for transplantation. They are specifically used to maintain lung function and viability during the critical period between organ retrieval and transplantation.
Practical Considerations
Perfadex solutions are typically used in conjunction with standard lung preservation techniques. Compatibility with existing perfusion systems is generally high, but clinicians should ensure proper handling and storage conditions. The solutions are available in standard volumes suitable for single lung preservation procedures.
Frequently Asked Questions
What is Perfadex and Perfadex with Tham used for?
Perfadex and Perfadex with Tham are used for the preservation of donor lungs during transplantation, helping maintain lung viability and function.
What specialties typically use this device?
Transplant surgeons and perfusionists in transplant centers use these solutions during lung transplantation procedures.
What are the FDA-cleared indications?
The solutions are indicated for the preservation of donor lungs intended for transplantation, ensuring they remain viable until implantation.
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.