Organ Donation & Transplant Matters Resources
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Organ Donation & Transplant Matters Resources
Combining reports, research findings and topic reviews
Curated by Deborah Verran
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US FDA approves XVIVO lung preservation device

US FDA approves XVIVO lung preservation device | Organ Donation & Transplant Matters Resources | Scoop.it

The U.S. Food and Drug Administration has approved the XVIVO Perfusion System (XPS) with STEEN Solution, a device for preserving donated lungs that do not initially meet the standard criteria for transplantation.

 

The XVIVO XPS lung perfusion system is one of several devices currently being trialed around the world. It is now hoped that with the judicious use of this type of technology that more donor lungs will be deemed suitable for transplantation. Once this technology becomes more widely available it is anticipated that this should lead to an increase in the numbers of lung transplants over the next 2-5 years.

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FDA Approves FibroScan(R) For Non-Invasive Liver Diagnosis

FDA Approves FibroScan(R) For Non-Invasive Liver Diagnosis | Organ Donation & Transplant Matters Resources | Scoop.it

Reported via Medical News Today. Echosens(TM) is pleased to announce that the FibroScan(R) device has received 510(k)clearance from the U.S. Food and Drug Administration (FDA) for use as a non-invasive method of  liver imaging.

 

The device is already in use in some parts of the world but penetrating the US market is now a significant development.

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FDA Panel Favors Device to Boost Lung Transplant Success - MedPage Today

FDA Panel Favors Device to Boost Lung Transplant Success - MedPage Today | Organ Donation & Transplant Matters Resources | Scoop.it

The news has come that an FDA Panel has given the approval for a normothermic lung preservation device to continue to be used in clinical research in order to boost lung transplant success as reported via MedPage Today.

 

A Canadian center involved in the HELP trial increased the proportion of donated lungs actually transplanted from 25% to 36% after starting to use the EXVIVO lung perfusion device. Of note there remains limited data for the medium to long term outcomes of lungs that have been transplanted after being preserved using this particular device. 

Deborah Verran's insight:

News that the EXVIVO lung preservation device has  received a preliminary limited approval by the FDA in the United States (humanitarian use device exemption)

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