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

Related Links:

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
Conclusion: Uremic environment but not inflammation per se increases plasma Lp-PLA2 activity and ulregulates monocytic Lp-PLA2 mRNA expression. The highest Lp-PLA2 levels were found in the classical and not in the inflammatory subsets. Atherosclerosis also contributes to a subset-specific increase in Lp-PLA2 mRNA expression.Nephron
Source: Nephron - Category: Urology & Nephrology Source Type: research
Conclusions: This study suggests that macrophage migratory inflammatory factor promoted the occurrence and development of uremic cardiomyopathy in patients with ESRD.
Source: Nigerian Journal of Clinical Practice - Category: Rural Health Authors: Source Type: research
CONCLUSIONS: Our pilot experience highlights the safety and efficacy of denosumab in the treatment of osteoporosis in HD patients, potentially supporting its use to reduce the burden of fractures in this patient population. PMID: 27394428 [PubMed - as supplied by publisher]
Source: Journal of Nephrology - Category: Urology & Nephrology Authors: Tags: J Nephrol Source Type: research
CONCLUSIONS: This study demonstrates that preoperative vascular mapping with a patient-centered approach may be critical to achieve good outcomes allowing the increase in AVF access. PMID: 27312756 [PubMed - as supplied by publisher]
Source: The Journal of Vascular Access - Category: Surgery Tags: J Vasc Access Source Type: research
Abstract Hemodialysis (HD) catheters are commonly used as temporary vascular access in patients with kidney failure who require immediate HD. The use of these catheters is limited by complications such as infections, thrombosis resulting in poor blood flow. We studied the complications and outcomes of nontunneled catheters used for vascular access in our dialysis unit. The records of all patients, with renal failure who were dialyzed over a two-year period and had a double lumen nontunneled catheter inserted, were retrieved. Catheter insertion was carried out under ultrasound guidance using the modified Seldinger ...
Source: Saudi Journal of Kidney Diseases and Transplantation - Category: Urology & Nephrology Authors: Tags: Saudi J Kidney Dis Transpl Source Type: research
Authors: Rusu CC, Ghervan L, Racasan S, Kacsa I, Moldovan D, Potra A, Bondor C, Anton F, Patiu IM, Gherman Caprioara M Abstract AIMS: The main cause of death in hemodialysis (HD) patients is cardiovascular disease. Ultrasound assessment of the brachial artery dysfunction is easily achievable and can non-invasively detect atherosclerosis in various stages. In HD patients the cardiovascular risk profile is different and the determinants of brachial arterial function can be distinct comparing with general population. The aim of the study is to assess the determinants of arterial brachial function (flow-mediated and ni...
Source: Medical Ultrasonography - Category: Radiology Tags: Med Ultrason Source Type: research
More News: Cardiology | Cardiovascular | Cardiovascular & Thoracic Surgery | Chronic Kidney Disease | Dialysis | Heart | Hemodialysis | Marketing | Medical Devices | Study | Ultrasound | Urology & Nephrology