Medtronic FDA Approval Marks a Turnaround in the Paclitaxel Story

Paclitaxel-coated balloons and paclitaxel-eluting stents caused quite the stir for manufacturers and physicians this year, but an FDA approval this week marks a major step forward for this category of devices. The agency approved Medtronic's IN.PACT AV drug-coated balloon for the treatment of failing arteriovenous access in patients with end-stage renal disease (ESRD) undergoing dialysis. AV fistulae are created and used to enable hemodialysis for patients with ESRD. Over time, vessel restenosis limits the ability to use AV fistulae effectively. In order to restore function, patients often undergo one to three maintenance procedures per year, which can result in significant disruptions to critical hemodialysis care and increased costs to the healthcare system. Pivotal randomized trial results from the IN.PACT AV Access trial have shown IN.PACT AV drug-coated balloon (DCB) can extend the time between reinterventions by maintaining AV access site patency, therefore maximizing a patient’s uninterrupted access to life-saving dialysis care. “In many cases, AV fistula are considered lifelines for patients with ESRD as they are the primary access point for life-saving dialysis treatment. When these access sites fail, patients experience delays in their dialysis treatment and require multiple reinterventions to keep the site functioning,” said Vincent Gallo, MD, intervent...
Source: MDDI - Category: Medical Devices Authors: Tags: Cardiovascular Source Type: news

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Conclusions: Our study results were not consistent with the hypothesis that PPI use increases MI risk among people without known heart disease.
Source: Epidemiology - Category: Epidemiology Tags: Cardiovascular Disease Source Type: research
Resumo Fundamento a caminhada n ão supervisionada em solo tem sido indicada para pacientes com doença arterial periférica (DAP) sintomática. No entanto, a magnitude do esforço exigido por essa atividade e as características dos pacientes que a praticam com mais intensidade não estão claras. Objetivos determinar se a cami nhada em solo excede o limiar ventilatório (LV), um reconhecido marcador de intensidade de exercício, em pacientes com DAP sintomática. Métodos Foram recrutados 70 pacientes (61,4% do sexo masculino e com idade entre 40 e 8...
Source: Arquivos Brasileiros de Cardiologia - Category: Cardiology Source Type: research
Resumo Fundamento a caminhada n ão supervisionada em solo tem sido indicada para pacientes com doença arterial periférica (DAP) sintomática. No entanto, a magnitude do esforço exigido por essa atividade e as características dos pacientes que a praticam com mais intensidade não estão claras. Objetivos determinar se a cami nhada em solo excede o limiar ventilatório (LV), um reconhecido marcador de intensidade de exercício, em pacientes com DAP sintomática. Métodos Foram recrutados 70 pacientes (61,4% do sexo masculino e com idade entre 40 e 8...
Source: Arquivos Brasileiros de Cardiologia - Category: Cardiology Source Type: research
AbstractTo identify the risk factors for restenosis at 1  year after aortoiliac stenting for symptomatic peripheral artery disease in real-world practice. We performed subgroup analysis of a large-scale prospective multicenter registry study enrolling Japanese patients with peripheral arterial disease who underwent aortoiliac endovascular therapy from Ap ril 2014 to April 2016. The subgroup comprised 880 patients (1108 limbs) who received iliac stenting. The Rutherford class was 2, 3, and 4 in 42%, 51%, and 7% of the patients, respectively. TASC II class D disease was noted in 18% of the patients and 35% had chronic t...
Source: Heart and Vessels - Category: Cardiology Source Type: research
We report a very rare case of a 67-year-old male with the presence of a common hepatic artery (CHA) arising from the left gastric artery (LGA) in association with a presence of a gastro-splenic trunk (GST), found incidentally on multidetector computed tomography (MDCT) angiography, used to investigate peripheral vascular disease. The GST arises from the anterior aspect of the abdominal aorta (AA), at the level of lower 1∕3 of L1 vertebral body. The GST has a slightly concave trajectory to the right, and ends dividing into splenic artery (SA) and LGA. In the initial part of its trajectory, the SA it is wedged at 180°,...
Source: Romanian Journal of Morphology and Embryology - Category: General Medicine Tags: Rom J Morphol Embryol Source Type: research
CONCLUSIONS: PTX-ITSs showed significantly better suppression of late scaffold shrinkage and lower in-scaffold stenosis for up to 3 months. Additionally, PTX-ITSs exhibited high biocompatibility, which is comparable to ITSs. PMID: 32238644 [PubMed - as supplied by publisher]
Source: Circulation Journal - Category: Cardiology Authors: Tags: Circ J Source Type: research
CONCLUSIONS: This study provides novel information regarding the probability of uneventful recovery while confirming low in-hospital mortality and stroke rates after elective aortic root replacement for aortic aneurysm. Importantly, uneventful recovery ensures excellent long-term survival. PMID: 32246934 [PubMed - as supplied by publisher]
Source: The Annals of Thoracic Surgery - Category: Cardiovascular & Thoracic Surgery Authors: Tags: Ann Thorac Surg Source Type: research
Conclusions: These results suggest that endothelial depalmitoylation is regulated by the metabolic milieu and controls plasma membrane partitioning to maintain vascular homeostasis. PMID: 32233916 [PubMed - as supplied by publisher]
Source: Circulation Research - Category: Cardiology Authors: Tags: Circ Res Source Type: research
AbstractObjectivesCentral or peripheral venoarterial extracorporeal membrane oxygenation (va ECMO) is widely used in postcardiotomy cardiogenic shock (PCS). Available data suggest controversial results for both types. Our aim was to investigate PCS patients treated with either peripheral (pECMO) or central ECMO (cECMO) concerning their outcome.MethodsBetween April 2006 and October 2016, 156 consecutive patients with va ECMO therapy due to PCS were identified and included in this retrospective analysis. Patients were divided into cECMO and pECMO groups. Statistical analysis of risk factors concerning 30 ‐day mortality of ...
Source: Journal of Cardiac Surgery - Category: Cardiovascular & Thoracic Surgery Authors: Tags: ORIGINAL ARTICLE Source Type: research
(American College of Cardiology) The results of VOYAGER PAD found that people with peripheral artery disease (PAD) who took the blood thinner rivaroxaban with aspirin after undergoing lower extremity revascularization -- a procedure to treat blocked arteries in the leg -- had a significant reduction in the risk of major adverse limb and cardiovascular events when compared with those receiving aspirin alone, according to a subgroup analysis from VOYAGER PAD presented at the American College of Cardiology's Annual Scientific Session Together with World Congress of Cardiology (ACC.20/WCC).
Source: EurekAlert! - Medicine and Health - Category: International Medicine & Public Health Source Type: news
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