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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Since the advent of lung transplantation, chronic lung allograft dysfunction (CLAD) has been the number one cause of long-term mortality.1 A subset of T cells, known as regulatory T cells (Tregs), have been shown to suppress inflammatory responses after organ transplantation. Much of what is known about the role of Tregs in suppressing alloimmune responses has come from experimental studies of kidney, heart, pancreatic islet, liver, and bone marrow transplantation. On the basis of these findings, 2 phase I clinical trials in which adoptively transferred Tregs were administered after kidney transplantation have been completed.
Source: The Journal of Thoracic and Cardiovascular Surgery - Category: Cardiovascular & Thoracic Surgery Authors: Tags: Commentary Source Type: research
Conclusions Cell-free DNA is a promising biomarker for monitoring the health of SOTs. Future studies will need to define how it can be used in routine clinical practice and determine clinical benefit with routine prospective monitoring.
Source: Transplantation - Category: Transplant Surgery Tags: Reviews Source Type: research
Purpose of review There is great variability in how different organ allografts respond to the same tolerance induction protocol. Well known examples of this phenomenon include the protolerogenic nature of kidney and liver allografts as opposed to the tolerance-resistance of heart and lung allografts. This suggests there are organ-specific factors which differentially drive the immune response following transplantation. Recent findings The specific cells or cell products that make one organ allograft more likely to be accepted off immunosuppression than another are largely unknown. However, new insights have been made ...
Source: Current Opinion in Organ Transplantation - Category: Surgery Tags: TRANSPLANT IMMUNOLOGY: REJECTION, TOLERANCE AND HISTOCOMPATIBILITY: Edited by Paolo Cravedi Source Type: research
Abstract PURPOSE OF REVIEW: There is great variability in how different organ allografts respond to the same tolerance induction protocol. Well known examples of this phenomenon include the protolerogenic nature of kidney and liver allografts as opposed to the tolerance-resistance of heart and lung allografts. This suggests there are organ-specific factors which differentially drive the immune response following transplantation. RECENT FINDINGS: The specific cells or cell products that make one organ allograft more likely to be accepted off immunosuppression than another are largely unknown. However, new insi...
Source: Current Opinion in Organ Transplantation - Category: Transplant Surgery Authors: Tags: Curr Opin Organ Transplant Source Type: research
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
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