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Abbott wins FDA nod for HeartMate 3 pump

Abbott (NYSE:ABT) said today that the FDA approved its HeartMate 3 implantable pump for heart failure patients awaiting a transplant. The approval is the latest for the HeartMate line of left ventricular assist devices first developed by Thoratec, which was later acquired by St. Jude Medical before a $25 billion merger brought it to Abbott earlier this year. Abbott said HeartMate 3 features full magnetic levitation for the pump’s impeller, aiming to cause less trauma to blood cells as they pass through the pump. Although it is smaller than its predecessor, Abbott claimed it has the industry’s largest “pump pathway.” The device won CE Mark approval in the European Union in October 2015. “Heart failure is a crippling and costly disease and the HeartMate 3 system is a big stride forward in giving patients the opportunity to return to better quality lives. Abbott is the pioneer and global leader in LVAD therapy and offers the broadest heart failure portfolio on the market to help physicians manage their patients from early to end-stage heart failure,” cardiac arrhythmias &heart failure CMO Dr. Mark Carlson said in prepared remarks. “In the Momentum 3 study, the HeartMate 3 system had no instances of suspected or established blood clotting within the pump at six months, which is a major milestone for those of us working tirelessly to improve clinical outcomes for patients living with advanced heart failure,” added Dr. M...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiac Assist Devices Food & Drug Administration (FDA) Abbott Source Type: news

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The HeartWare Ventricular Assist System (HVAD) provides significant improvements in survival and quality of life, and here, we seek to evaluate temporal differences in the adverse event (AE) rates. Patients (n = 382) in the ADVANCE bridge-to-transplant and continued access protocol trial were assessed for bleeding, cardiac arrhythmia, infection, ischemic and hemorrhagic stroke, and right heart failure during predetermined time periods (≤30,>30–180,>180–365,>365–730,>730–1,095 days) after HVAD implant. The Kaplan–Meier survival at 30 days, 6 months, 1, 2, and 3 years was 98%, 90%...
Source: ASAIO Journal - Category: Medical Devices Tags: Adult Circulatory Support Source Type: research
Orthotopic heart transplantation (OHT) has revolutionized the care of advanced, drug refractory heart failure (HF). Surgical technique, medical management, and donor and recipient selection have continued to evolve. However, OHT has also been accompanied by both forseeable and unintended cardiovascular and systemic conditions such as cardiac allograft vasculopathy (CAV), cardiometabolic disease, malignancy, infection, and arrhythmias. Cardiac arrhythmias may arise by multiple mechanisms that include acute allograft rejection, chronic rejection, remodeling and fibrosis that allow for reentry, and unknown or unrealized donor...
Source: The Journal of Heart and Lung Transplantation - Category: Transplant Surgery Authors: Source Type: research
Orthotopic heart transplantation (OHT) has revolutionized the care of advanced, drug-refractory heart failure. Surgical technique, medical management, and donor and recipient selection have continued to evolve. However, OHT has also been accompanied by foreseeable and also unintended cardiovascular and systemic conditions such as cardiac allograft vasculopathy (CAV), cardiometabolic disease, malignancy, infection, and arrhythmias. Cardiac arrhythmias may arise by multiple mechanisms, including acute allograft rejection, chronic rejection, remodeling and fibrosis that allow for reentry, and unknown or unrealized donor arrhythmic substrates.
Source: The Journal of Heart and Lung Transplantation - Category: Transplant Surgery Authors: Tags: Editorial Source Type: research
Publication date: Available online 18 July 2017 Source:Best Practice & Research Clinical Anaesthesiology Author(s): Marlena V. Habal, A. Reshad Garan End-stage heart failure manifests as severe and often relentless symptoms that define the clinical syndrome of heart failure, namely congestion and hypoperfusion. These patients suffer from dyspnea, fatigue, abdominal discomfort and ultimately cardiac cachexia. Renal and hepatic dysfunction frequently further complicate the process. Recurrent hospitalizations, cardiac arrhythmias, and intolerance to standard heart failure therapies are common as the disease progresses. M...
Source: Best Practice and Research Clinical Anaesthesiology - Category: Anesthesiology Source Type: research
CONCLUSIONS: There is currently insufficient evidence to determine whether erythrocytapheresis is beneficial or harmful compared with phlebotomy. Phlebotomy has less equipment requirements and remains the treatment of choice in people with hereditary haemochromatosis who require blood letting in some form. However, it should be noted that there is no evidence from randomised clinical trials that blood letting in any form is beneficial in people with hereditary haemochromatosis. Having said this, a trial including no treatment is unlikely to be conducted. Future trials should compare different frequencies of phlebotomy and ...
Source: Cochrane Database of Systematic Reviews - Category: Journals (General) Authors: Tags: Cochrane Database Syst Rev Source Type: research
Advanced heart failure patients who are classified as bridge to transplant (BTT) often remain on mechanical circulatory support (MCS) for long durations because of the limited supply of donor organs. Here, we present the outcomes of patients who have been supported by the HeartWare ventricular assist device system for more than 2 years. In the HeartWare BTT and continued access protocol trial, 74 of the 382 total patients (19.4%) had more than 2 years of MCS with a mean time of 1,045 days on device. The long-term group was more frequently female, was nonwhite, and had Interagency Registry for Mechanically Assisted Circulat...
Source: ASAIO Journal - Category: Medical Equipment Tags: Adult Circulatory Support Source Type: research
Last week, I mentioned the case of Dr. Neil Spector, whose long-undiagnosed Lyme Disease resulted in irreversible heart failure and ultimately, a heart transplant. Dr. Spector, author of Gone in a Heartbeat: A Physician's Search for True Healing, is the Sandra Coates Associate Professor of Medicine and Associate Professor of Pharmacology and Cancer Biology at Duke University School of Medicine. As the Director of Developmental Therapeutics at the Duke Cancer Institute, he's a leader in applying translational research to the clinical development of molecularly targeted personalized cancer therapies. Here, Dr. Spector share...
Source: Science - The Huffington Post - Category: Science Source Type: news
Please wait while the activity loads. If this activity does not load, try refreshing your browser. Also, this page requires javascript. Please visit using a browser with javascript enabled. If loading fails, click here to try again Click on the 'Start' button to begin the mock test. After answering all questions, click on the 'Get Results' button to display your score and the explanations. There is no time limit for this mock test. Start Congratulations - you have completed DM / DNB Cardiology Entrance Mock Test 7. You scored %%SCORE%% out of %%TOTAL%%. Your performance has been rate...
Source: Cardiophile MD - Category: Cardiology Authors: Tags: Cardiology MCQ DM / DNB Cardiology Entrance Featured Source Type: blogs
ConclusionsThe study suggests that an increased ventilatory response during exercise might reveal a preclinical manifestation of DCM in LMNA mutation carriers.
Source: Clinical Physiology and Functional Imaging - Category: Radiology Authors: Tags: Original Article Source Type: research
Atrial fibrillation (AF) is the most common chronic cardiac arrhythmia, often found in patients with heart failure requiring a ventricular assist device. Our goal was to assess the effect of preoperative AF on the risk of thromboembolic (TE) events (hemolysis, stroke and/or TIA), clinical outcomes and survival in patients receiving a continuous-flow left ventricular assist device (CF-LVAD).
Source: The Journal of Heart and Lung Transplantation - Category: Transplant Surgery Authors: Source Type: research
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