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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Peripheral artery disease (PAD) in the lower extremities is a common complication of type 2 diabetes and has been shown to be associated with mortality. The ankle-brachial index (ABI) is a simple noninvasive m...
Source: Cardiovascular Diabetology - Category: Cardiology Authors: Tags: Original investigation Source Type: research
Council on Peripheral Vascular Disease; and Stroke Council Abstract There is mounting evidence that lesbian, gay, bisexual, transgender, and queer or questioning (LGBTQ) adults experience disparities across several cardiovascular risk factors compared with their cisgender heterosexual peers. These disparities are posited to be driven primarily by exposure to psychosocial stressors across the life span. This American Heart Association scientific statement reviews the extant literature on the cardiovascular health of LGBTQ adults. Informed by the minority stress and social ecological models, the objectives of this s...
Source: Circulation - Category: Cardiology Authors: Tags: Circulation Source Type: research
Authors: De Luca L, Bonaca MP, Magnani G Abstract INTRODUCTION: Patients with coexisting coronary artery disease (CAD) and peripheral artery disease (PAD) present a very high rate of cardiovascular (CV) morbidity and mortality. Several studies have demonstrated that different regimens of antithrombotic therapies may reduce adverse CV events in patients with CAD or PAD. However, data on optimal antithrombotic combination to use in these very high-risk patients are scarce and conflicting. AREAS COVERED: This paper reviews current data on antithrombotic therapies tested in CAD patients with concomitant lower extre...
Source: Expert Review of Cardiovascular Therapy - Category: Cardiology Tags: Expert Rev Cardiovasc Ther Source Type: research
Cardiovascular complications represent the major cause of morbidity and mortality of type 2 diabetes mellitus (T2DM) patients. In particular, peripheral artery disease (PAD) represents a frequent T2DM vascular...
Source: Cardiovascular Diabetology - Category: Cardiology Authors: Tags: Original investigation Source Type: research
Conclusion: In the absence of an association between the presence of PAD and collateral scores or outcomes after EVT, it may be questioned whether PAD leads to RIPC in patients with acute ischemic stroke due to large vessel occlusion.
Source: Frontiers in Neurology - Category: Neurology Source Type: research
Treatment of femoropopliteal peripheral artery disease (PAD) using paclitaxel-coated devices (PCD) has been shown to improve patency in several randomized trials. However, a recent meta-analysis of trial data suggested an increased risk of mortality with the use of this technology. Although subsequent studies have found no association with mortality, the subject remains controversial. Thus, the aim of this study is to further investigate outcomes and causes of mortality in patients treated with PCDs.
Source: Journal of Vascular Surgery - Category: Surgery Authors: Source Type: research
Abstract BACKGROUND: Patients with a patient-reported penicillin allergy may be at greater risk for postoperative prosthetic joint infection (PJI) after total joint arthroplasty of the hip, knee, or shoulder. The increased risk of PJI in these patients has been attributed to these patients receiving a less-effective perioperative antibiotic. However, prior reports did not fully address the clinical characteristics of these unique patients, who may inherently be at greater risk of having a PJI, which may confound prior findings. QUESTIONS/PURPOSES: After controlling for risk factors for PJI such as BMI, anxiet...
Source: Clinical Orthopaedics and Related Research - Category: Orthopaedics Authors: Tags: Clin Orthop Relat Res Source Type: research
DABRA RA-308 Excimer Laser, SN: ******* - Product Usage: The device is intended for use in ablating a channel in occlusive peripheral vascular disease.
Source: Medical Device Recalls - Category: Medical Devices Source Type: alerts
This study was designed to determine the feasibility and safety of robotic PVI for treating femoropopliteal lesions with drug-coated balloon (DCB), and to evaluate the effect of robotic PVI on operator radiation exposure during robotic PVI. METHODS: This prospective, single-arm trial enrolled patients with symptomatic peripheral arterial disease affecting the femoropopliteal artery. The primary outcome measure was clinical success, defined as
Source: The Journal of Invasive Cardiology - Category: Cardiology Tags: J Invasive Cardiol Source Type: research
Atherosclerosis (AS) is the main pathological basis of coronary heart disease, cerebral infarction and peripheral vascular disease, which seriously endanger people ’s life and health. In recent years, long non-...
Source: Biological Research - Category: Biomedical Science Authors: Tags: Research article Source Type: research
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