Medtronic wins FDA nod for thoracotomy-based HVAD procedure

Medtronic (NYSE:MDT) said today it won FDA approval for thoracotomy-based implantation procedures with its HVAD left ventricular assist device, which it said is a less-invasive implantation approach. The Fridley, Minn.-based medtech giant touted the approval as the first for any commercially available LVAD in the US, and said that the clearance came based on data from the Lateral clinical trial of the device. The 44-patient trial met its primary endpoint of non-inferiority, with data indicating an 88.1% rate of survival at six months free from disabling stroke or device explant or exchange due to malfunction. Results also indicated a reduction in hospital stay length, down from an average of 26.1 days to 18 days, Medtronic said. Overall survival amongst patients who underwent a thoracotomy-based HVAD implantation was 88.8% at one year, Medtronic said. “We have demonstrated that a thoracotomy is a safe and effective implant technique for the HVAD system, which gives physicians added flexibility in treating a broad range of patients. Implanting the HVAD via thoracotomy preserves the chest for a subsequent procedure that patients may need, such as a heart transplant. It also has been shown to result in shorter hospital stays,” Lateral trial principal investigator Dr. Edwin McGee Jr. of the Loyola University Medical Center said in a prepared statement. The company said that along with the approval, it has released tools designed to assist specifically with the th...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiac Implants Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Medtronic Source Type: news

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Authors: Wróbel-Dudzińska D, Alio J, Rodriguez A, Suchodoła-Ratajewicz E, Kosior-Jarecka E, Rymgayłło-Jankowska B, Ćwiklińska-Haszcz A, Żarnowski T Abstract Purpose: Platelet-rich plasma (PRP) is an autologous blood product without preservatives and rich in proteins and growth factors which make it possible for cells to differentiate, proliferate, and migrate, thus stimulating healing and regeneration of tissues. The aim of this study was to evaluate the efficiency of autologous platelet-rich plasma in the treatment of neurotrophic keratopathy. Methods: The study group consists of 25 patients with...
Source: Journal of Ophthalmology - Category: Opthalmology Tags: J Ophthalmol Source Type: research
CONCLUSION: Women with STEMI are less likely to receive invasive management, revascularisation, or preventive medication at discharge. The reasons for these persistent differences in care require investigation. PMID: 30025513 [PubMed - as supplied by publisher]
Source: Medical Journal of Australia - Category: General Medicine Tags: Med J Aust Source Type: research
Fight Aging! provides a weekly digest of news and commentary for thousands of subscribers interested in the latest longevity science: progress towards the medical control of aging in order to prevent age-related frailty, suffering, and disease, as well as improvements in the present understanding of what works and what doesn't work when it comes to extending healthy life. Expect to see summaries of recent advances in medical research, news from the scientific community, advocacy and fundraising initiatives to help speed work on the repair and reversal of aging, links to online resources, and much more. This content is...
Source: Fight Aging! - Category: Research Authors: Tags: Newsletters Source Type: blogs
ConclusionsThe Gambia has a very low ICU bed capacity and lacks the human resources and equipment necessary to diagnose and treat the large number of critically ill patients admitted to public hospitals in the country.
Source: Journal of Critical Care - Category: Gastroenterology Source Type: research
“Summer means happy times and good sunshine. It means going to the beach, going to Disneyland, having fun.” – Brian Wilson “Summertime, and the livin’ is easy…” Great lyrics by George Gershwin from the classic song he wrote for the 1935 musical Porgy and Bess. Summertime should be a time for individuals, families and friends to spend together doing what makes them laugh, enjoy each other’s’ company, and contribute to everyone’s overall well-being. In the middle of vacation or weekend getaway planning, or just carving time out of your busy schedule for some fun ac...
Source: World of Psychology - Category: Psychiatry & Psychology Authors: Tags: Habits Happiness Source Type: blogs
ConclusionIn carotid artery dissections, prodromal symptoms such as transient ischemic attack, like in our patient, are rarely present in children. For good long term outcomes, it is very important to suspect, diagnose and initiate appropriate treatment in a rapid manner in carotid artery dissection before severe neurological findings such as acute ischemic stroke develops.
Source: Journal of Clinical Neuroscience - Category: Neuroscience Source Type: research
Publication date: Available online 21 July 2018Source: Journal of Clinical NeuroscienceAuthor(s): Danfeng Zhang, Xianliang Dai, Chaoqun Wang, Kaiwei Han, Junyu Wang, Yan Dong, Jigang Chen, Lijun HouAbstractAortic valve calcification (AVC) is common among aged population and reported to be associated with the risk of stroke. However, the conclusions are inconsistent among studies. We performed a rigorous meta-analysis to unravel the AVC-stroke relationship. Embase, PubMed and Cochrane library were retrieved for related cohort studies investigating the correlations between AVC and risk of stroke. The language was limited to ...
Source: Journal of Clinical Neuroscience - Category: Neuroscience Source Type: research
Publication date: Available online 21 July 2018Source: Journal of Clinical NeuroscienceAuthor(s): Zhaohong Kong, Yan Hong, Jiang Zhu, Xin Cheng, Yumin LiuAbstractTo investigate the role of venous infusion of endothelial progenitor cells (EPCs) in the reendothelialization of acute focal cerebral ischemia model in rats. And explore the mechanism of VEGF to promote angiogenesis of functional recovery in focal cerebral ischemia of rat. A model of middle cerebral artery occlusion (MCAo) was used to mimic ischemia following EPCs extraction from the same donor rats. EPCs were characterized by CD34, CD45 and CD133 expressions, and...
Source: Journal of Clinical Neuroscience - Category: Neuroscience Source Type: research
Substantial data during the last three decades has focused on lipid intervention for the prevention and treatment of atherosclerosis and, more importantly, on the primary and secondary prevention of major cardiovascular disease (CVD) events, including coronary heart disease (CHD) and stroke [1]. Certainly, the majority of the attention during recent decades has been directed at lowering the levels of low-density lipoprotein cholesterol (LDL-C), although some studies have also directed attention at lowering levels of triglycerides (TGs) and/or raising levels of the cardio-protective high-density lipoprotein cholesterol (HDL-C).
Source: International Journal of Cardiology - Category: Cardiology Authors: Tags: Editorial Source Type: research
Atrial fibrillation is a common cause of stroke, and diabetes increases stroke risk. Stroke risk may vary depending on the type of diabetes. We investigated whether type 1 and type 2 diabetes are associated with different risks of thromboembolism among patients with atrial fibrillation.
Source: International Journal of Cardiology - Category: Cardiology Authors: Source Type: research
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