CardiacAssist wins 510(k) for TandemLung

CardiacAssist said today it won FDA 510(k) clearance for its TandemLung oxygenator designed to operate as an artificial lung by infusing oxygen and removing carbon dioxide from the blood. The Pittsburgh, Penn.-based company said the TandemLung is designed so it can be used along with its TandemHeart blood pump, and combined the devices “represent a leap forward in extracorporeal life support technology for patients in need of critical cardiopulmonary care.” “After our original TandemHeart pump was cleared for use with an oxygenator in 2011, our team immediately began working with experts in the field to understand how to reduce the complexity of cardiopulmonary bypass technology so that more patients could receive this potentially life-saving procedure. The design of the TandemLung is a direct result of those efforts.  This release represents our 6th new product clearance since September 2013, and we are proud to dedicate ourselves to improving the lives of patients by delivering innovative, easy-to-use devices for simplified life support,” CEO John Marous said in prepared remarks. CardiacAssist said that only a small portion of the more than 300,000 patients who experience an acute cardiac or respiratory event that requires emergency intervention receive advanced life support like its Tandem products, due to the complexity of deploying the technology. The company said its TandemLung was designed for simplicity and performance ...
Source: Mass Device - Category: Medical Equipment Authors: Tags: 510(k) Food & Drug Administration (FDA) Regulatory/Clearance Respiratory CardiacAssist Inc. Source Type: news

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Source: Fight Aging! - Category: Research Authors: Tags: Newsletters Source Type: blogs
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Source: Seizure: European Journal of Epilepsy - Category: Neurology Authors: Tags: Review Source Type: research
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Source: The Journal of Heart and Lung Transplantation - Category: Transplant Surgery Authors: Tags: Original Clinical Science 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...
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Conditions:   Respiratory Failure;   Hepatitis C Intervention:   Drug: Clinically prescribed direct acting antiviral (Mavyret or Epclusa) HCV treatment for 12 weeks Sponsor:   Massachusetts General Hospital Not yet recruiting
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