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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Abstract Rescuing patients with the development of acute respiratory distress syndrome and right heart failure after left ventricular assist device placement remains a challenge in patients with congenital heart disease. TandemLife Protek Duo (TandemLife, Pittsburg, PA) is a double-lumen cannula introduced via the internal jugular vein that can provide veno-venous extra-corporeal membrane oxygenation and right heart support. To our knowledge, we report the first case of successfully using the TandemLife Protek Duo cannula to provide veno-venous extra-corporeal membrane oxygenation and right ventricle support in an...
Source: Perfusion - Category: Cardiovascular & Thoracic Surgery Authors: Tags: Perfusion Source Type: research
Conclusions: After the unilateral lung transplantation, both perfusion and ventilation were gradually and continuously decreased in non-transplanted lung. Both Tc-99m MAA perfusion scintigraphy and Kr-81m lung ventilation scintigraphy was useful tool for monitoring respiratory function in patients who would be undergone unilateral lung transplantation.
Source: Journal of Nuclear Medicine - Category: Nuclear Medicine Authors: Tags: Infection/Pulmonary/Outcomes (Poster Session) Source Type: research
EVLP allows for reassessment of lung grafts initially deemed unsuitable for transplantation, increasing the available donor pool, however this requires a pre and post-EVLP period of cold ischemic time (CIT). Paucity of data exist on how the sequence of cold-normothermic-cold preservations affect outcomes.
Source: The Journal of Heart and Lung Transplantation - Category: Transplant Surgery Authors: Tags: Original Clinical Science Source Type: research
Ex vivo lung perfusion (EVLP) allows for a reassessment of lung grafts initially deemed unsuitable for transplantation, increasing the available donor pool; however, this requires a pre- and post-EVLP period of cold ischemic time (CIT). Paucity of data exists on how the sequence of cold normothermic –cold preservations affect outcomes.
Source: The Journal of Heart and Lung Transplantation - Category: Transplant Surgery Authors: Tags: ORIGINAL CLINICAL SCIENCE Source Type: research
Authors: Koch A, Pizanis N, Bessa V, Slama A, Aigner C, Taube C, Kamler M Abstract Background: The low acceptance rates in lung transplantation underline the importance to use every potential transplantable organ. With the use of normothermic ex vivo lung perfusion (EVLP) there is a potential to use more donor lungs for transplantation. Aim of this study was to evaluate if EVLP has an effect on cytomegalovirus (CMV) infection after lung transplantation. Methods: Between May 2016 and October 2018, 57 lung transplants were performed. Out of these 21 extended criteria lungs were evaluated by EVLP and 16 transplant...
Source: Journal of Thoracic Disease - Category: Respiratory Medicine Tags: J Thorac Dis Source Type: research
Organ transplantation is undergoing profound changes. Contraindications for donation have been revised in order to better meet the organ demand. The use of lower-quality organs and organs with greater preoperative damage, including those from donation after cardiac death (DCD), has become an established routine but increases the risk of graft malfunction. This risk is further aggravated by ischemia and reperfusion injury (IRI) in the process of transplantation. These circumstances demand a preservation technology that ameliorates IRI and allows for assessment of viability and function prior to transplantation. Oxygenated h...
Source: Frontiers in Immunology - Category: Allergy & Immunology Source Type: research
Purpose of review Lung transplantation offers the only realistic therapeutic option for patients with end-stage lung disease. However, this is impacted by a shortfall in availability of suitable donor-lungs. Normothermic machine perfusion of donor-lungs outside the donor body also known as ex-vivo lung perfusion (EVLP) offers a potential solution through objective assessment, reconditioning and treatment of donor-lungs initially deemed unsuitable for use. This review discusses key advances and challenges in the wider clinical adoption of this technology. Recent findings This review will summarize key research within t...
Source: Current Opinion in Organ Transplantation - Category: Surgery Tags: LUNG TRANSPLANTATION: Edited by Jasleen Kukreja Source Type: research
AbstractLung transplantation is currently the only curative treatment for patients with end-stage lung disease; however, donor organ shortage and the need for intense immunosuppression limit its broad clinical application. Bioartificial lungs created by combining native matrix scaffolds with patient-derived cells might overcome these problems. Decellularization involves stripping away cells while leaving behind the extracellular matrix scaffold. Cadaveric lungs are decellularized by detergent perfusion, and histologic examination confirms the absence of cellular components but the preservation of matrix proteins. The resul...
Source: Surgery Today - Category: Surgery Source Type: research
Ramadan and colleagues1 have outlined a reliable method for testing the impact of varying concentrations of oxaliplatin with in  vivo lung perfusion (IVLP). This group has pioneered ex vivo lung perfusion for treatment of donor lungs for transplant. Now, they have added the effort to treat the lung in vivo for cancer.
Source: The Journal of Thoracic and Cardiovascular Surgery - Category: Cardiovascular & Thoracic Surgery Authors: Tags: Commentary Source Type: research
One in five children with end-stage lung failure (ESLF) die while awaiting lung transplant. No suitable animal model of ESLF exists for the development of artificial lung devices for bridging to transplant. Small lambs weighing 15.7 ± 3.1 kg (n = 5) underwent ligation of the left anterior pulmonary artery (PA) branch, and gradual occlusion of the right main PA over 48 hours. All animals remained hemodynamically stable. Over seven days of disease model conditions, they developed pulmonary hypertension (mean PA pressure 20 ± 5 vs. 33 ± 4 mm Hg), decreased perfusion (SvO2 66 ± 3 vs. 55 ± 8%)...
Source: ASAIO Journal - Category: Medical Devices Tags: Pulmonary Source Type: research
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