FDA panel recommends approval for TransMedics lung transplant device

An FDA advisory panel yesterday recommended that the federal safety watchdog approve a device made by TransMedics to keep donated lungs perfused during transport to transplantation procedures. The FDA’s Gastroenterology & Urology Devices panel voted 11-2 that the OCS Lung system is safe; 8-5 that it’s effective; and 9-4 that its benefits outweigh the risks, an FDA spokeswoman told MassDevice.com via email. TransMedics did not respond to a request for comment. A previously scheduled advisory panel hearing for another TransMedics device, the OCS Heart system, was cancelled by the FDA in November 2015. The agency told MassDevice.com at the time that “FDA has determined that an advisory committee is no longer needed to discuss the premarket approval application” for the OCS Heart device. In February 2016 TransMedics launched a pivotal study of its OCS Liver device, comparing compare liver transplantation using the the device with the standard of care – transplantation using a liver preserved on ice. The primary endpoints are incidence of early liver allograft dysfunction at 7 days and incidence of liver graft-related serious adverse events at 30 days. Final data collection for the primary endpoint is slated for October. Last July TransMedics added nearly $13 million to a $51 million equity round. The post FDA panel recommends approval for TransMedics lung transplant ...
Source: Mass Device - Category: Medical Devices Authors: Tags: Food & Drug Administration (FDA) Regulatory/Compliance Gastroenterology & Urology Devices panel Organ Transplant Transmedics Inc. Source Type: news

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Fight Aging! provides a weekly digest of news and commentary for thousands of subscribers interested in the latest longevity science: progress towards the medical control of aging in order to prevent age-related frailty, suffering, and disease, as well as improvements in the present understanding of what works and what doesn't work when it comes to extending healthy life. Expect to see summaries of recent advances in medical research, news from the scientific community, advocacy and fundraising initiatives to help speed work on the repair and reversal of aging, links to online resources, and much more. This content is...
Source: Fight Aging! - Category: Research Authors: Tags: Newsletters Source Type: blogs
ConclusionsIn this study, we found that circulating complement-activating anti-HLA DSAs had a significant deleterious impact on solid organ transplant survival and risk of rejection. The detection of complement-activating anti-HLA DSAs may add value at an individual patient level for noninvasive biomarker-guided risk stratification. Trial registrationNational Clinical Trial protocol ID: NCT03438058.
Source: PLoS Medicine - Category: Internal Medicine Authors: Source Type: research
In this study we investigated regulatory t cells after combined lung and liver transplantation, or after isolated lung transplantation, in cystic fibrosis patients and correlated the findings with long term outcomes
Source: The Journal of Heart and Lung Transplantation - Category: Transplant Surgery Authors: Source Type: research
Short-term outcomes of solid organ transplantation have improved dramatically over the past several decades; however, long-term survival has remained static over the same period, and chronic rejection remains a major cause of graft failure. The importance of donor, or “passenger,” lymphocytes to the induction of tolerance to allografts was recognized in the 1990s, but their precise contribution to graft acceptance or rejection has not been elucidated. Recently, specialized populations of tissue-resident lymphocytes in nonlymphoid organs have been described. These lymphocytes include tissue-resident memory T cel...
Source: Transplantation - Category: Transplant Surgery Tags: Reviews Source Type: research
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Source: American Journal of Transplantation - Category: Transplant Surgery Authors: Tags: Minireview Source Type: research
In conclusion, evaluation of patient selection for heart transplantation should be comprehensive and individualized with respect to indications and the risk of comorbidities of candidates. With the advancement of mechanical circulatory support (MCS), the selection of heart transplantation candidate is continuously evolving and widened. MCS as bridge to candidacy should be considered when the candidate has potentially reversible risk factors for transplantation.
Source: Current Cardiology Reports - Category: Cardiology Source Type: research
Abstract The number of nonrenal solid‐organ transplants increased substantially in the last few decades. Many of these patients develop renal failure and receive kidney transplantation. The aim of this study was to evaluate patient and kidney allograft survival in primary, repeat, and kidney‐after‐nonrenal organ transplantation using national data reported to United Network for Organ Sharing (UNOS) from January 2000 through December 2014. Survival time for each patient was stratified into the following: Group A (comparison group)—recipients of primary kidney transplant (178 947 patients), Group B—rec...
Source: Clinical Transplantation - Category: Transplant Surgery Authors: Tags: ORIGINAL ARTICLE Source Type: research
This article is protected by copyright. All rights reserved.
Source: Clinical Transplantation - Category: Transplant Surgery Authors: Tags: Original Article Source Type: research
Purpose of review: BK virus is a significant risk factor for kidney allograft dysfunction and loss among renal transplant recipients. Currently, there is no proven effective treatment except for the reduction of immunosuppression. In this review, we discuss diagnostic challenges and current treatment options for BK in kidney transplant recipients. Recent findings: Antiviral and antibiotic therapies have been employed for BK viraemia with variable efficacy. In addition, novel therapeutic regimens such as adoptive transfer of targeted T cells have been described as possible treatment options for recipients with BK nephropat...
Source: Current Opinion in Organ Transplantation - Category: Surgery Tags: INFECTIOUS COMPLICATIONS IN TRANSPLANTATION: Edited by Kiran K. Dhanireddy Source Type: research
Abstract: Several groups have reported extended survival of genetically engineered pig organs in nonhuman primates, varying from almost 10 months for life-supporting kidney grafts and more than 2 years for non–life-supporting heart grafts to less than 1 month for life-supporting liver and lung grafts. We have attempted to define groups of patients who may not have an option to wait for an allograft. These include kidney, heart, and lung candidates who are highly-allosensitized. In addition, some kidney candidates (who have previously lost at least 2 allografts from rapid recurrence of native kidney disease) have a hi...
Source: Transplantation - Category: Transplant Surgery Tags: Reviews Source Type: research
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