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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American Journal of Transplantation, EarlyView.
Source: American Journal of Transplantation - Category: Transplant Surgery Authors: Source Type: research
Aortic valve incompetence in left ventricular assist device (LVAD) patients is a significant management problem, leading to increased workload on the LVAD and inadequate systemic perfusion. During continuous LVAD therapy even mild aortic incompetence is problematic, associated with reduced aortic leaflet opening, progressive fusion of the leaflets and worsening valvular incompetence. Therefore, repair or replacement of the valve is required at the time of LVAD implant.
Source: The Journal of Heart and Lung Transplantation - Category: Transplant Surgery Authors: Tags: Case Anecdotes, Comments and Opinions Source Type: research
Normothermic ex-vivo lung perfusion (EVLP) is a new emerging technique to select lungs from extended-criteria donors. These lungs present edema due to brain-death, harvesting, preservation, or ischemia-reperfusion. However, the identification of appropriate organs is crucial. Combined bench techniques during EVLP rehabilitation are proposed to better assess lung function and predict an adequate graft [1 –3]. However, accurate assessment of the lungs remains challenging because the common tools are insufficiently correlated to the occurrence and severity of primary graft dysfunction (PGD) in recipients.
Source: The Journal of Heart and Lung Transplantation - Category: Transplant Surgery Authors: Tags: Original Clinical Science Source Type: research
Authors: Salehi S, Tran K, Grayson WL Abstract In the past, a diagnosis of organ failure would essentially be a death sentence for patients. With improved techniques for organ procurement and surgical procedures, transplantations to treat organ failure have become standard medical practice. However, while the demand for organs has skyrocketed, the donor pool has not kept pace leading to long recipient waiting lists. Organ preservation provides a means to increase the number of available transplantable organs. However, there are significant drawbacks associated with cold storage, the current gold standard. To addres...
Source: The Yale Journal of Biology and Medicine - Category: Universities & Medical Training Tags: Yale J Biol Med Source Type: research
American Journal of Transplantation,Volume 0, Issue ja, -Not available-.
Source: American Journal of Transplantation - Category: Transplant Surgery Authors: Source Type: research
Abstract PURPOSE OF REVIEW: Recent progress in genetic engineering has facilitated development of transgenic donor animals designed to overcome the known barriers to discordant xenotransplantation, and greatly accelerated progress in the field of xenotransplantation. Here we review and summarize recent progress in lung xenotransplantation, and discuss possible additional genetic modifications and other interventions that may further advance the use of pulmonary xenografts towards clinical applications based on known mechanisms of xeno lung injury. RECENT FINDINGS: Ex-vivo lung perfusion experiments have shown...
Source: Current Opinion in Organ Transplantation - Category: Transplant Surgery Authors: Tags: Curr Opin Organ Transplant Source Type: research
Conclusion Our developed orthotopic NSCLC tumours have similarity with biological growth behaviour comparable to that seen in the clinic and could therefore be used as attractive models to study tumour biology and evaluate new therapeutic strategies. The use of human cancer cell lines facilitates testing of different genomic tumour profiles that may affect treatment outcomes. Advances in knowledge The combination of different imaging modalities to identify tumour growth with subsequent use in treatment planning and orthotopic transplantation techniques to develop initially single lesions to ultimate metastases pave the way...
Source: The British Journal of Radiology - Category: Radiology Authors: Tags: Br J Radiol Source Type: research
AbstractPurpose of ReviewThere is a shortage of lungs available to meet the needs of patient who require lung transplantation. Ex vivo lung perfusion (EVLP) has allowed for the assessment and reconditioning of extended criteria and high-risk donor lungs, allowing for an increased volume of lung transplants. Recently, an invested interest in the utilization donation after cardiac death (DCD) donors has surfaced, in which EVLP has played an important role.Recent FindingsClinical studies have shown that EVLP can recondition donor lungs that initially would be unacceptable for transplantation. In a recent study, the interventi...
Source: Current Respiratory Care Reports - Category: Respiratory Medicine Source Type: research
Abstract The field of lung transplant has made significant advances over the past several decades. Despite these advances, morbidity and mortality remain high when compared with other solid organ transplants. As the field moves forward, the speed by which progress can be made will in part be determined by our ability to overcome several stumbling blocks including: donor shortage, proper selection of candidates, primary graft dysfunction, and chronic lung allograft dysfunction. The advances and developments surrounding these factors will have a significant impact on shaping the field within the coming years. In thi...
Source: Chest - Category: Respiratory Medicine Authors: Tags: Chest Source Type: research
Authors: Rosso L, Zanella A, Righi I, Barilani M, Lazzari L, Scotti E, Gori F, Mendogni P Abstract Lung transplantation is the only therapeutic option for end-stage pulmonary failure. Nevertheless, the shortage of donor pool available for transplantation does not allow to satisfy the requests, thus the mortality on the waiting list remains high. One of the tools to overcome the donor pool shortage is the use of ex-vivo lung perfusion (EVLP) to preserve, evaluate and recondition selected lung grafts not otherwise suitable for transplantation. EVLP is nowadays a clinical reality and have several destinations of use. ...
Source: Journal of Thoracic Disease - Category: Respiratory Medicine Tags: J Thorac Dis Source Type: research
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