Medtronic ’s HVAD System Just Became Less Invasive

Medtronic has gained FDA approval for a less-invasive implant approach of its HVAD System, a left ventricular assist device (LVAD) for advanced heart failure patients. The Dublin-based company picked up the technology when it acquired HeartWare in 2016. The firm said the technology is the only LVAD approved in the U.S. for implant via thoracotomy, a small lateral, surgical incision between the patient's ribs on the left side of the chest. FDA approval for HVAD implantation via thoracotomy is based on data from the LATERAL prospective clinical trial, in which 144 patients, with end-stage heart failure who were eligible for heart transplant, were enrolled at 26 centers in the U.S. and Canada. The primary endpoint of the trial demonstrated non-inferiority of the HVAD implanted in patients via thoracotomy, where survival at six months free from disabling stroke or device explant or exchange due to malfunction was achieved in 88.1% of patients. Since the success outcome exceeded the pre-specified performance goal of 77.5%, the trial achieved its primary endpoint (p=0.0012). The key secondary endpoint revealed a significant reduction in total length of hospital stay, from an average of 26.1 days down to 18 days (p
Source: MDDI - Category: Medical Devices Authors: Tags: Cardiovascular Business Source Type: news

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Authors: Frich JC Abstract Henrik Ibsen (1828-1906) is a Norwegian playwright and poet who is known as the father of modern drama. Ibsen was in good health when he announced at his 70th birthday celebration that he intended to continue writing. His last play, When We Dead Awaken, was published in 1899. Why did Ibsen's dramatic writing come to an end? This chapter presents a medical account of Ibsen's health condition during the last 6 years of his life. It is based on a review of a document written by one of his doctors, Edvard Bull (1845-1925), letters, biographic information, and Ibsen's death certificate. The hi...
Source: Frontiers of Neurology and Neuroscience - Category: Neuroscience Tags: Front Neurol Neurosci Source Type: research
Abbott (NYSE:ABT) said today it won FDA approval for its HeartMate 3 left ventricular assist device, now approved as a destination therapy for patients with advanced heart failure. With the approval, the Chicago-based company said that the device can now be used in patients not eligible for a transplant as a life-long implant. “We partner with physicians to holistically develop therapies that benefit patients and achieve better outcomes. The unique design of the HeartMate 3 LVAD—with its Full MagLev technology—takes an established innovation and improves upon it in meaningful ways to help people with...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiac Implants Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Abbott Source Type: news
Conclusions Clinicians should consider patient age and history of stroke, peripheral vascular disease, or anxiety/panic disorders when optimizing a lower limb prosthesis users' mobility because these variables may be predictive of modest but clinically meaningful decreased prosthetic mobility. By contrast, common comorbid health conditions such as arthritis, chronic obstructive pulmonary disease, congestive heart failure, and diabetes do not seem predictive of decreased mobility among lower limb prosthesis users.
Source: American Journal of Physical Medicine and Rehabilitation - Category: Rehabilitation Tags: Original Research Articles Source Type: research
Conclusion of first report:In patients with anterior Killip class II or less ST-segment –elevation myocardial infarction undergoing primary percutaneous coronary intervention, early intravenous metoprolol before reperfusion reduced infarct size and increased left ventricular ejection fraction with no excess of adverse events during the first 24 hours after STEMI.Conclusion of 2nd report: In patients with anterior Killip class  ≤II STEMI undergoing pPCI, early IV metoprolol before reperfusion resulted in higher long-term LVEF, reduced incidence of severe LV systolic dysfunction and ICD indications, and fe...
Source: Dr. Smith's ECG Blog - Category: Cardiology Authors: Source Type: blogs
No one ever had fun visiting the cardiologist. ­Regardless of how good the doc might be, it’s always a little scary thinking about the health of something as fundamental as the heart. But there are ways to take greater control—to ensure that your own heart health is the best it can be—even if you have a family history of cardiovascular disease. Although 50% of cardiovascular-disease risk is genetic, the other 50% can be modified by how you live your life, according to Dr. Eugenia Gianos, director of Women’s Heart Health at Lenox Hill Hospital in New York City. “This means you can greatly ...
Source: TIME: Health - Category: Consumer Health News Authors: Tags: Uncategorized Baby Boomer Health heart health Source Type: news
CONCLUSION: In this study assessing atherectomy in obese patients, OA and RA demonstrated comparable outcomes with complication rates within an acceptable range. It demonstrates that OA and RA can be safely performed in this high-risk patient subset with CAC. PMID: 30318482 [PubMed - as supplied by publisher]
Source: The Journal of Invasive Cardiology - Category: Cardiology Tags: J Invasive Cardiol Source Type: research
AbstractPurpose of ReviewAtrial fibrillation (AF) is the most common sustained cardiac arrhythmia in humans, affecting more than 33 million people globally. Its association with complex, resource intensive medical conditions such as stroke, heart failure and dementia have had profound impacts across existing health care structures. The global prevalence of AF has enjoyed significant growth despite significant improvement in our armamentarium for arrhythmia treatment.Recent FindingsEfforts aimed at curtailing the incidence, prevalence, or progression of AF have prompted re-evaluation of traditional frameworks for understand...
Source: Current Cardiology Reports - Category: Cardiology Source Type: research
Conclusions: The MARS-5 is a feasible and valid self-assessed medication adherence for older patients with stroke. In addition, several determinants were found to be related to medication adherence for older patients with stroke. Healthcare providers may want to take heed of these determinants to improve medication adherence for this population.
Source: Journal of Cardiovascular Nursing - Category: Nursing Tags: ARTICLES: Heart Failure Source Type: research
Conclusions: Portable bladder ultrasound scanning reduced the incidence of UTI and shortened length of stay. We suggest routine PBU procedures for patients with acute ischemic stroke who fulfill the AGN3 criteria for a high risk of UTI.
Source: Journal of Cardiovascular Nursing - Category: Nursing Tags: ARTICLES: Heart Failure Source Type: research
AbstractDue to its poor capacity for regeneration, the heart is particularly sensitive to the loss of contractile cardiomyocytes. The onslaught of damage caused by ischaemia and reperfusion, occurring during an acute myocardial infarction and the subsequent reperfusion therapy, can wipe out upwards of a billion cardiomyocytes. A similar program of cell death can cause the irreversible loss of neurons in ischaemic stroke. Similar pathways of lethal cell injury can contribute to other pathologies such as left ventricular dysfunction and heart failure caused by cancer therapy. Consequently, strategies designed to protect the ...
Source: Basic Research in Cardiology - Category: Cardiology Source Type: research
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