Ellipsys ' FDA Nod Is a Major Turning Point for Hemodialysis

A new catheter-based technology could provide a non-surgical option for arteriovenous (AV) fistula creation. FDA recently gave de novo clearance to Avenu Medical’s Ellipsys Vascular Access System. The San Juan Capistrano, CA-based company’s device challenges the surgical option to create an AV fistula, which has been the gold standard for about 50 years. “This is what we call a disruptive technology for sure,” Ed Chang, Co-Founder, Director and VP Marketing for Avenu, told MD+DI. “We liken this to lap chole. Prior to lap chole it was always done surgically. That was the gold standard until laparscopic technology entered the system. We believe the same thing is going to happen with the Avenu technology with percutaneous AV Fistula creation.” The device can make an AV fistula or a connection to veins and arteries in patients with chronic kidney disease who need hemodialysis. In Europe where the technology has been available since 2016, patients call the Ellipsys procedure the “scarless fistula.” "What we’ve done at Avenu is come up with an AV fistula without surgery,” Chang said. “We go in with a single catheter venous access and we go in and under ultrasound guidance we create the fistula. We actually fuse the vein and artery together and we quickly are able to remove the catheter and the fistula is formed without doing a surgery… you walk out with a band aid.” FDA reviewed data from a non-rand...
Source: MDDI - Category: Medical Devices Authors: Tags: Business Source Type: news

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A 67-year-old man began hemodialysis at age 44 years after undergoing a right nephrectomy. Whereas a preoperative ultrasound had revealed mild renal atrophy in the absence of cysts, the histopathologic analysis of the excised kidney was consistent with nonspecific chronic kidney disease. During the following decade, the remaining kidney became severely polycystic (Figure  1a and b), and the liver was occupied by several microcysts in the absence of hepatocellular dysfunction or cholestasis based on serum measurements.
Source: Kidney International - Category: Urology & Nephrology Authors: Tags: Nephrology Image Source Type: research
Guangwen Luo1†, Bailiang Li1†, Cailu Yang2†, Yutang Wang1, Xin Bian1, Wan Li1, Fei Liu1 and Guicheng Huo1* 1Key Laboratory of Dairy Science, Ministry of Education, College of Food Science, Northeast Agricultural University, Harbin, China 2Department of Ultrasound, Maternal and Child Health Hospital of Dapeng New District, Shenzhen, China Modulating gut microbiota to promote host health is well recognized. Therefore, people consume dietary products containing traditional probiotics in wishing to improve their health, and they need more research-based advices on how to select products with sui...
Source: Frontiers in Microbiology - Category: Microbiology Source Type: research
Discussion: Incomplete septal cirrhosis is an uncommon cause of non-cirrhotic portal hypertension. Its definition is not well known, morphological and pathophysiological. We have not found published cases of post-RT ascites secondary to this pathology, described as possibly associated with drugs, immune alterations, infections, hypercoagulability and genetic predisposition. PMID: 30897191 [PubMed - as supplied by publisher]
Source: Jornal Brasileiro de Nefrologia - Category: Urology & Nephrology Tags: J Bras Nefrol Source Type: research
Conclusions: Renal disease proved to be associated with early and subclinical impairment of LV systolic function, which persists after starting dialysis and even in spite of successful kidney transplantation. An increased E/e ’ resulted to be the most powerful independent predictor of abnormal GLS.Cardiorenal Med 2019;9:61 –68
Source: Cardiorenal Medicine - Category: Urology & Nephrology Source Type: research
Conclusion: Community acquired AKI is a major health problem with high morbidity and mortality.Nephron
Source: Nephron - Category: Urology & Nephrology Source Type: research
Abstract Endothelial progenitor cells (EPCs) CD34 are bone marrow-derived cells that decrease in chronic kidney disease (CKD) patients especially when they reach end-stage renal disease and may be a risk marker of cardiovascular (CV) diseases. The aim of our study is to investigate the endothelial progenitor cell CD 34 numbers in children with CKD on regular hemodialysis (HD) and detect their association with vascular stiffness. We recruited 25 children on regular HD, who were selected from the HD unit of Al-Zahraa Hospital, Al-Azhar University. Another group of 25 age and sex matched healthy children served as as...
Source: Saudi Journal of Kidney Diseases and Transplantation - Category: Urology & Nephrology Authors: Tags: Saudi J Kidney Dis Transpl Source Type: research
Protein-Energy Wasting (PEW) is a pathological condition of renal patients with advanced Chronic Kidney Disease characterized by a progressive reduction of energy and protein assets. Nutritional status assessment, especially for what concerns muscle mass, is essential for both the identification of patients at risk for the development of PEW, as well as monitoring the effects of nutritional interventions. Ultrasound methods are easily applicable at the bedside for quantitative assessment of skeletal muscle.
Source: Clinical Nutrition - Category: Nutrition Authors: Tags: Original article Source Type: research
This study aimed to assess the association between frailty and bone loss in patients undergoing hemodialysis. This cross-sectional study included 214 (90 women, 124 men) Japanese outpatients undergoing maintenance hemodialysis three times per week, with a mean age of 67.1  years (women) and 66.8 years (men). Frailty was defined based on criteria set forth by the Cardiovascular Health Study (CHS)—19 (21.1%) women and 47 (37.9%) men were robust, 41 (45.6%) women and 43 (34.7%) men were pre-frail, and 30 (33.3%) women and 34 (27.4%) men were frail. For bone mass, qu antitative ultrasound (QUS) parameters (spee...
Source: Journal of Bone and Mineral Metabolism - Category: Orthopaedics Source Type: research
Objective:We explored the nerve ultrasound (US) characteristics of 15 patients with end-stage kidney disease (ESKD) and correlated these findings with clinical severity and electrophysiological parameters of neuropathy.Background:Peripheral neuropathy is highly prevalent in chronic kidney disease (CKD), occurring in 90–100% of patients receiving dialysis and causes significant functional disability. With increasing incidence of CKD and end-stage kidney disease, the need to develop new biomarkers for early detection and management of neuropathy is paramount.Our previous studies have demonstrated changes in nerve funct...
Source: Neurology - Category: Neurology Authors: Tags: Neuromuscular and Clinical Neurophysiology (EMG): Peripheral Neuropathy I Source Type: research
by Enric S ánchez, Àngels Betriu, David Arroyo, Carolina López, Marta Hernández, Ferran Rius, Elvira Fernández, Albert Lecube Advanced glycation end-products (AGEs) are increased and predict mortality in patients with chronic kidney disease (CKD) who are undergoing hemodialysis, irrespective of the presence of type 2 diabetes. However, little information exits about the relationship between AGEs and subclinical atheroscl erosis at the early stages of CKD. A case-control study was performed including 87 patients with mild-to-moderate stages of CKD (glomerular filtration rate from 89 to 30...
Source: PLoS One - Category: Biomedical Science Authors: Source Type: research
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