FDA sets a date to review XVIVO's lung perfusion system

The FDA sets a date to consider Humanitarian Device Exemption for XVIVO's perfusion system for preserving donor lungs. Sweden-based XVIVO Perfusion landed a date with the FDA to review Humanitarian Device Exemption for its XVIVO Perfusion System for preserving donor lungs. XVIVO will meet on March 20 with the FDA's Gastroenterology &Urology Devices Panel to review data on the device, which provides continuous perfusion of otherwise unacceptable lung tissue, allowing clinicians to reevaluate the organs for transplantation. News Well, Humanitarian Device Exemption (HDE), Regulatory/Clearance, Food &Drug Administration (FDA), Organ Transplantread more
Source: Mass Device - Category: Medical Equipment Authors: Tags: Food & Drug Administration (FDA) XVIVO Perfusion Source Type: news

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We report the first case on the use of EVLP followed by separate transplantation in two different centres. The local organ procurement organization proposed the lungs of a 53-year-old non-smoker donor who died for cerebral haemorrhage. P/F ratio was 294 after lung recruitment manoeuvres. Oto score was 10. Two centres accepted the grafts for two single transplantations under the condition of EVLP evaluation. After usual retrieval, the bi-pulmonary block was transferred to Centre 1 and EVLP was run as previously described. At the end of the procedure the two lungs were evaluated separately and both judged suitable for transp...
Source: Journal of Thoracic Disease - Category: Respiratory Medicine Tags: J Thorac Dis Source Type: research
ConclusionMultiparametric pulmonary MRI is feasible in lung allografts within an EVLP system. Oxygen-enhanced imaging seems to be a promising marker for ischemic injury, enabling detection of affected lung segments prior to transplantation.
Source: Academic Radiology - Category: Radiology Source Type: research
Transplant International,Volume 0, Issue ja, -Not available-.
Source: Transplant International - Category: Transplant Surgery Authors: Source Type: research
ConclusionMultiparametric pulmonary MRI is feasible in lung allografts within an EVLP system. Oxygen-enhanced imaging seems to be a promising marker for ischemic injury, enabling detection of affected lung segments prior to transplantation.
Source: Academic Radiology - Category: Radiology Source Type: research
Lung transplantation has become standard treatment for end-stage pulmonary disease. Although the number of lung transplants has increased over the last decade, the availability of suitable donor lungs remains an issue.1 Although several strategies have been adopted to expand the donor pool, such as by including extended-criteria donors and ex-vivo lung perfusion after cardiac death, mortality continues to rise among patients waiting for a suitable donor lung.2,3 Although brain-dead donors are still the main source of organs for lung transplantation, brain death also triggers hemodynamic, metabolic, inflammatory, and neuroe...
Source: The Journal of Heart and Lung Transplantation - Category: Transplant Surgery Authors: Tags: ORIGINAL PRE-CLINICAL SCIENCE Source Type: research
The FDA approved a new medical device for patients suffering from severe emphysema. The Pulmonx Zephyr Endobronchial Valve is a one-way valve system to be implanted through the airways using a traditional bronchoscope. The valve is integrated into a ...
Source: Medgadget - Category: Medical Devices Authors: Tags: Medicine Thoracic Surgery Source Type: blogs
CONCLUSIONS: Our report confirmed the comparable outcome from DCD donors compared with DBD donors. Utility of DCD donors is a safe option to overcome donor shortage. PMID: 29962390 [PubMed - as supplied by publisher]
Source: Annals of Thoracic and Cardiovascular Surgery - Category: Cardiovascular & Thoracic Surgery Authors: Tags: Ann Thorac Cardiovasc Surg Source Type: research
CONCLUSION: Ex vivo lung perfusion can safely be used in the evaluation of lungs initially considered not suitable for transplantation. The primary outcome was not negatively affected and normothermic ex vivo lung perfusion is a useful tool to increase the usage of potentially transplantable lungs. PMID: 29976122 [PubMed - as supplied by publisher]
Source: The International Journal of Artificial Organs - Category: Transplant Surgery Authors: Tags: Int J Artif Organs Source Type: research
Ex Vivo Lung Perfusion (EVLP) is a system that circulates normothermic perfusate into procured lungs, allowing for improved lung function and lung assessment. We investigated whether ventilation with hydrogen gas during EVLP improves the donation after cardiac death (DCD) lung function, and whether this effect persists after actual transplantation.
Source: The Journal of Heart and Lung Transplantation - Category: Transplant Surgery Authors: Tags: Original Pre-Clinical Science Source Type: research
Conclusion Multiparametric pulmonary MRI is feasible in lung allografts within an EVLP system. Oxygen-enhanced imaging seems to be a promising marker for ischemic injury, enabling detection of affected lung segments prior to transplantation.
Source: Academic Radiology - Category: Radiology Source Type: research
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