TransMedics wins FDA approval for OCS Lung transplant system

TransMedics said today that it won pre-market approval from the FDA for its OCD Lung transplant system, which is designed to keep donated human lungs in near-living condition until transplantation. The March 22 approval covers standard double-lung transplantation procedures, Andover, Mass.-based TransMedics said. The federal safety watchdog granted the PMA based on data from the 316-patient Inspire trial, the results from which were published this week in The Lancet Respiratory Medicine, comparing OCS lung with the standard of care – cold flush and storage. Inspire met its primary outcome – a composite of patient survival rate at 30 days and the rate of absence of International Society for Heart &Lung Transplantation primary graft dysfunction Grade 3 within 72 hours – and its three secondary outcomes of rate of ISHLT) PGD Grade 3 alone at 72 hours, rate of ISHLT PGD Grade 2 or 3 at 72 hours and patient survival at 30 days. The study’s authors also found other benefits to using OCS Lung, according to a TransMedics press release [The Lancet Respiratory Medicine site was down as of this writing]. “The OCS Lung device significantly reduced primary graft dysfunction Grade 3 within the initial 72 hours after lung transplantation. To our knowledge, this is the first reported clinical, pre-emptive therapy to reduce the incidence of severe PGD3 in lung transplantation,” the authors wrote. “This reduction of PGD3 in the OCS g...
Source: Mass Device - Category: Medical Devices Authors: Tags: Clinical Trials Regulatory/Compliance Respiratory Transplants Wall Street Beat transmedics Source Type: news

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Source: Fight Aging! - Category: Research Authors: Tags: Newsletters Source Type: blogs
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Source: Fight Aging! - Category: Research Authors: Tags: Newsletters Source Type: blogs
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Source: Current Opinion in Organ Transplantation - Category: Surgery Tags: LIVER TRANSPLANTATION: Edited by R. Mark Ghobrial Source Type: research
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Source: Current Opinion in Organ Transplantation - Category: Transplant Surgery Authors: Tags: Curr Opin Organ Transplant Source Type: research
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Source: Fight Aging! - Category: Research Authors: Tags: Newsletters Source Type: blogs
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Source: Fight Aging! - Category: Research Authors: Tags: Medicine, Biotech, Research Source Type: blogs
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Source: Fight Aging! - Category: Research Authors: Tags: Newsletters Source Type: blogs
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Source: The Journal of Heart and Lung Transplantation - Category: Transplant Surgery Authors: Source Type: research
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Source: Journal of Stem Cells - Category: Stem Cells Tags: J Stem Cells Source Type: research
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Source: Clinical and Translational Imaging - Category: Radiology Source Type: research
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