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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This study aims to describe the features of patients who cannot be weaned from iNO, the reasons for this and its impact on postoperative outcomes.MethodsThis is a monocentric cohort study comprised all consecutive patients who underwent double ‐lung transplantation (DLT) between January 1st, 2012 and January 1, 2016. The impact of iNO dependency on postoperative outcomes was estimated using a boosted inverse probability of treatment weighting estimator.Results9.8% of the 173 patients included in the study could not be weaned from iNO at end ‐surgery stage. Body mass index (OR=2.03, 95%CI=1.14‐3.29, p=0.02) and intrao...
Source: Transplant International - Category: Transplant Surgery Authors: Tags: Original Article Source Type: research
Lung transplantation has become an accepted therapy for most causes of end-stage lung disease. Between 30 to 50% of lung transplants require extracorporeal life support (ECLS). In many lung transplantation centers, extracorporeal membrane oxygenation (ECMO) is replacing cardiopulmonary bypass (CPB) as the primary choice for intraoperative ECLS. This review will discuss the evolving role of ECMO in lung transplantation and its implications for anesthetic management.
Source: Journal of Cardiothoracic and Vascular Anesthesia - Category: Anesthesiology Authors: Tags: Review Article Source Type: research
Publication date: December 2018Source: The Annals of Thoracic Surgery, Volume 106, Issue 6Author(s): Scott Chicotka, Felipe E. Pedroso, Cara L. Agerstrand, Erika B. Rosenzweig, Darryl Abrams, Tom Benson, Aimee Layton, Daniel Burkhoff, Daniel Brodie, Matthew D. BacchettaBackgroundExtracorporeal membrane oxygenation (ECMO) as a bridge to lung transplantation for end-stage interstitial lung disease (ILD) and pulmonary hypertension (PH) has varying results based on ECMO configuration. We compare our experience using venovenous (VV) and venoarterial (VA) ECMO bridge to transplantation for ILD with PH on survival to successful t...
Source: The Annals of Thoracic Surgery - Category: Cardiovascular & Thoracic Surgery Source Type: research
ConclusionsThe trajectory of physical HRQOL in patients receiving SLT declines over time compared with DLT, indicating that, in the longer term, SLT recipients are more likely to have physical HRQOL scores that fall substantively below general population norms. Physical HRQOL after 5 years may be a consideration for lung allocation and patient counseling regarding expectations when recommending SLT or DLT.
Source: The Annals of Thoracic Surgery - Category: Cardiovascular & Thoracic Surgery Source Type: research
ConclusionsDCD lung transplants remain underused in the United States. Nevertheless, survival is similar to DBD. Primary graft dysfunction metrics for DCDs are worse than DBDs on intensive care arrival but improved subsequently.Visual Abstract
Source: The Annals of Thoracic Surgery - Category: Cardiovascular & Thoracic Surgery Source Type: research
Abstract Redox-active compounds such as copper-phenanthroline are known as artificial/chemical nucleases with a great impact and potential for their applications as metallotherapeutics. In that vein, the mononuclear copper(II) complexes [Cu(L)2(bipy)] (1), [Cu(L)2(bipy)(H2O)] (2) and [Cu(L)2(phen)(H2O)] (3), where L = 2-thiophene carboxylate, bipy = 2,2΄-bipyridine and phen = 1,10-phenanthroline, have been prepared and pharmacochemically studied, while the crystal structure of 1 is also reported. All the tested complexes preferably bind to CT-DNA via minor groove as resulted from UV spectroscopy studi...
Source: Appl Human Sci - Category: Physiology Authors: Tags: Mater Sci Eng C Mater Biol Appl Source Type: research
AbstractMucopolysaccharidoses (MPS) are a group of hereditary disorders caused by lysosomal storage of glycosaminoglycans (GAGs) and characterized by a wide variability of phenotypes from severe fetal-neonatal forms to attenuated diseases diagnosed in adult individuals. The clinical picture generally worsens with age due to progressive storage involving mucosal tissue, upper airways and lungs, bones and joints, central and peripheral nervous system, heart, liver, eye, and ear. Cardiac storage of GAGs involves valves, heart muscle, and vessels (particularly the coronary arteries), and can be specific in relation to differen...
Source: Italian Journal of Pediatrics - Category: Pediatrics Source Type: research
Source: The Journal of Heart and Lung Transplantation - Category: Transplant Surgery Source Type: research
Source: The Journal of Heart and Lung Transplantation - Category: Transplant Surgery Source Type: research
Source: The Journal of Heart and Lung Transplantation - Category: Transplant Surgery Source Type: research
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