📋 FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Preservation of donor lungs intended for transplantation.
- Use during the retrieval, storage, transport, and preparation of donor lungs before implantation.
Clinical Applications
- Flushing donor lungs during organ retrieval.
- Preserving donor lungs during transport from the donor hospital to the transplant center.
- Maintaining donor-lung viability during storage before transplantation.
- Preparing donor lungs for implantation in a lung-transplant recipient.
Practical Considerations
- Use is limited to specialized transplant settings and trained transplant surgeons, perfusionists, and operating-room personnel.
- The solution must be handled, stored, and administered according to the current product labeling and transplant-center protocol.
- Perfadex is used with established lung-retrieval and preservation techniques; compatibility with the organ-preservation circuit or perfusion equipment should be confirmed before use.
- The product is a preservation solution, not an implantable device, and it does not remain in the recipient as a permanent treatment.
- Contraindications, warnings, preparation requirements, and available container volumes should be checked in the current FDA-cleared labeling and package insert.
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.