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perfadex with tham
Vitrolife Sweden Ab
Summary: Perfadex with THAM is a medical device used primarily in organ transplantation procedures, specifically lung transplants. It is utilized by transplant surgeons and healthcare teams to preserve donor lungs during transportation.
FDA Clearance Information
Pathway
510K
Number
K081997 ↗
Decision Date
October 9, 2008
Product Code
MSB
Device Class
Class 2
Evidence
0 studies
Perfadex with THAM was cleared through the FDA 510(k) pathway on October 9, 2008. Manufactured by Vitrolife Sweden Ab, it is classified as a Class 2 medical device.
What It Is
Perfadex with THAM is a preservation solution used in lung transplantation. It is designed to maintain the viability of donor lungs during transport from the donor to the recipient. The solution helps to reduce cellular damage by providing an optimal environment, including pH balance and osmotic conditions, to preserve lung tissue integrity.
Clinical Applications
Perfadex with THAM is commonly used in the setting of lung transplantation, a procedure performed by transplant surgeons in specialized centers. It is crucial during the ex vivo phase when the donor lung is outside the body. This solution is particularly important for patients with end-stage lung diseases awaiting transplantation, ensuring the organ remains viable for successful implantation.
Indications for Use
The FDA-cleared indication for Perfadex with THAM is for the preservation of donor lungs intended for transplantation. It is specifically used to keep the lungs viable during the critical period between organ harvest and transplantation into the recipient.
Practical Considerations
Perfadex with THAM should be used according to the manufacturer's guidelines, ensuring proper temperature and handling to maintain its efficacy. It is compatible with standard organ preservation protocols and equipment used in transplant centers.
Frequently Asked Questions
What is Perfadex with THAM used for?
Perfadex with THAM is used for preserving donor lungs during transportation for transplantation.
What specialties typically use this device?
Transplant surgeons and healthcare professionals in organ transplant centers use this device.
What are the FDA-cleared indications?
Perfadex with THAM is indicated for the preservation of donor lungs for transplantation.
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.