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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Publication date: Available online 18 April 2019Source: Journal of Sport and Health ScienceAuthor(s): Xin Luan, Xiangyang Tian, Haixin Zhang, Rui Huang, Na Li, Peijie Chen, Ru WangAbstractA growing understanding of the benefits of exercise over the past few decades has prompted researchers to take an interest in the possibilities of exercise therapy. Because each sport has its own set of characteristics and physiological complications that tend to appear during exercise training, the effects and underlying mechanisms of exercise remain unclear. Thus, the first step in probing exercise effects on different diseases is the s...
Source: Journal of Sport and Health Science - Category: Sports Medicine Source Type: research
We describe a novel approach for bilateral lung transplantation as off-pump technique via median sternotomy which has the potential to combine the advantages of median sternotomy with less postoperative pain and better chest wall function and off-pump technique with reduced risk of primary graft dysfunction and bleeding complications.
Source: The Annals of Thoracic Surgery - Category: Cardiovascular & Thoracic Surgery Source Type: research
(Reuters Health) - In many parts of the world there are not enough radiation oncologists to design and deliver radiation treatments for lung cancer patients, but that gap could one day be filled with the help of artificial intelligence, researchers suggest in a new study.
Source: Reuters: Health - Category: Consumer Health News Tags: healthNews Source Type: news
In conclusion, a reliable and robust LC-MS/MS method was developed to quantify erlotinib in hair, however, clinical and in vitro evaluations showed that the method is not suitable for monitoring long term erlotinib exposure. The pitfalls of this application outweigh the current benefits.
Source: Journal of Pharmaceutical and Biomedical Analysis - Category: Drugs & Pharmacology Source Type: research
Condition:   Cystic Fibrosis Intervention:   Procedure: Extracorporeal Life Support Sponsor:   Policlinico Hospital Completed
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
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Source: American Journal of Physical Medicine and Rehabilitation - Category: Rehabilitation Tags: Original Research Articles Source Type: research
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Source: Medscape Today Headlines - Category: Consumer Health News Tags: Transplantation Journal Article Source Type: news
Conclusion: This case of thyroid bed PG supports the idea that PG reflects a cutaneous phenotype encompassed in the spectrum of systemic neutrophilic diseases. Endocrinologists should be aware that thyroid bed PG involvement is an albeit rare differential diagnosis to consider in patients who had undergone thyroid surgery, especially with a history of PG. Introduction Papillary thyroid carcinoma (PTC), the main variant of differentiated thyroid carcinoma (DTC), is the most common thyroid cancer, accounting for 70–80% of all thyroid carcinomas and occurring predominantly in women, generally with a good prognos...
Source: Frontiers in Endocrinology - Category: Endocrinology Source Type: research
Conclusions MDSC are major players in the immunosuppressive scenario in cancer, thanks to their phenotype heterogeneity and critical interaction with several innate immune cells, thus representing a crucial target in oncology. Here we reviewed the interactions of MDSCs with NK cells. The contribution of key cytokines, chemokines and mediators active in this process have been discussed. We also described the contribution of MDSC on angiogenesis directly or indirectly through interactions with NK and immunosuppressive activities. A parallel of the cancer associated to the decidual counterpart of these cells is discussed, a...
Source: Frontiers in Immunology - Category: Allergy & Immunology Source Type: research
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Source: Frontiers in Immunology - Category: Allergy & Immunology Source Type: research
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