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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Ex vivo lung perfusion (EVLP) has been proposed as a platform for lung graft assessment and preservation. However, its proinflammatory milieu may be associated with deterioration in graft quality which may contribute to posttransplant graft dysfunction. Triptolide (TL), a diterpenoid triepoxide, has recently been shown to have a therapeutic potential in various disease states due to its anti-inflammatory properties. Based on this, we sought to assess the impact of TL on graft preservation during EVLP as well as associated posttransplant outcomes.
Source: The Journal of Heart and Lung Transplantation - Category: Transplant Surgery Authors: Tags: 11 Source Type: research
Ex vivo lung perfusion (EVLP) enables novel therapeutic approaches to repair damaged lungs for transplantation. We investigated the concept and feasibility of elective cell therapy for donor lungs. Dosing, efficacy and transgene expression kinetics of engineered mesenchymal stromal cell therapy were examined in pig EVLP and transplantation.
Source: The Journal of Heart and Lung Transplantation - Category: Transplant Surgery Authors: Tags: 8 Source Type: research
In the setting of Cardiogenic Shock (CS), impaired biventricular function can lead to an acute decrease in renal function via reduced renal perfusion and increased renal venous pressure. In a nationally representative sample, we sought to analyze the characteristics and outcomes of patients hospitalized with CS requiring renal replacement therapy (hemodialysis) for acute kidney injury (AKI-HD).
Source: The Journal of Heart and Lung Transplantation - Category: Transplant Surgery Authors: Tags: 132 Source Type: research
The OPTN/UNOS added fields to the deceased donor registration form on 3/31/2015 and the transplants recipient registration (TRR) form on 2/28/2018 to collect data on the utilization of ex vivo lung perfusion (EVLP) on donor lung. The steadily increasing use of EVLP, early outcomes, and new data collected on the TRR are summarized.
Source: The Journal of Heart and Lung Transplantation - Category: Transplant Surgery Authors: Tags: 112 Source Type: research
The risk of post-transplant lymphoproliferative disorder (PTLD), a B-cell malignancy caused by Epstein-Barr virus (EBV), is highest when latent virus is transmitted from B-cells within the allograft to a na ïve recipient. Ex-vivo lung perfusion (EVLP) is a potential platform to modify grafts before transplantation. We hypothesized that EVLP-mediated delivery of Rituximab (RTX), an antibody targeting CD20+ B-cells, may safely clear latent EBV from donor lungs and attenuate viral transmission.
Source: The Journal of Heart and Lung Transplantation - Category: Transplant Surgery Authors: Tags: 110 Source Type: research
In pre-clinical studies we have demonstrated the ability of light-based therapies - UVC and photodynamic therapy (PDT) during EVLP to inactivate HCV in donor lungs. In a step-wise application of this technology to clinical transplantation, we designed a clinical trial to evaluate to effects of UVC treatment using NAT+ HCV donor lungs followed by transplantation.
Source: The Journal of Heart and Lung Transplantation - Category: Transplant Surgery Authors: Tags: 108 Source Type: research
Ex vivo lung perfusion (EVLP) has become an invaluable tool in clinical lung transplantation (LTx). EVLP has enabled the assessment and rescue of donor organs that would have otherwise been discarded for LTx; however, determining which marginal organs are suitable for transplant remains challenging and relies largely on clinical assessment expertise. To this end, we describe our efforts to develop and validate a perfusate-based diagnostic test that will assist transplant teams in the EVLP decision-making process.
Source: The Journal of Heart and Lung Transplantation - Category: Transplant Surgery Authors: Tags: 107 Source Type: research
To avoid asystole during the ablation of the heart to improve the viability of the heart using the normothermic perfusion in Langendorff mode as a preservation method during ablation avoiding chemical cryopreservation.
Source: The Journal of Heart and Lung Transplantation - Category: Transplant Surgery Authors: Tags: 85 Source Type: research
We present a series of patients who underwent heart transplantation at our unit using a novel implantation technique to reduce PGD that is cost-effective and reproducible
Source: The Journal of Heart and Lung Transplantation - Category: Transplant Surgery Authors: Tags: 83 Source Type: research
Ex vivo organ perfusion is an advanced preservation technique that allows graft assessment and extended ex situ intervals. We hypothesized that its properties for prolonged heart preservation might be especially beneficial for high risk recipients.
Source: The Journal of Heart and Lung Transplantation - Category: Transplant Surgery Authors: Tags: 82 Source Type: research
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