Trial shows BD balloon compares well with angioplasty for CLI

BD (NYSE: BDX) today touted the results of a clinical trial that showed “statistically significant safety equivalence” between its Lutonix 014 drug-coated balloon (DCB) and a standard angioplasty catheter (PTA) in treating narrowed or obstructed arteries below the knee. The trial’s primary safety endpoint—freedom from composite all-cause death, above the ankle or major reintervention of the treated limb through 30 days—was met in both the proportional and binary and Kaplan Meier analyses of patient survival following a medical procedure. BD presented the trial results during a late-breaking clinical trials session at the Vascular Interventional Advances (VIVA) conference in Las Vegas. Get the full story on our sister site, Medical Design &Outsourcing. The post Trial shows BD balloon compares well with angioplasty for CLI appeared first on MassDevice.
Source: Mass Device - Category: Medical Devices Authors: Tags: Blog Catheters Clinical Trials Featured Research & Development Vascular BD Vascular Interventional Advances (VIVA) Source Type: news

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ConclusionsSeverity of venous collateralization on the venogram at presentation of patients with PSS does not appear to affect success of endovascular therapy but may predict long-term patency of affected extremities. Patients in this cohort with severe collateralization on presentation were more likely to need repeat intervention.
Source: Journal of Vascular and Interventional Radiology - Category: Radiology Source Type: research
AbstractDrug-coated balloon (DCB) angioplasty has been shown to be a promising option for the treatment of coronary in-stent restenosis (ISR). We compared the clinical outcomes of patients with ISR who were treated with two commonly used paclitaxel-containing DCBs, the Pantera Lux (PL) and SeQuent Please (SP). A total of 491 patients with 507 ISR lesions [PL-DCB in 127 (26%) patients and SP-DCB in 364 (74%) patients] underwent DCB angioplasty for ISR lesions. The major adverse cardiac events (MACEs), including cardiac death, target lesion-related myocardial infarction, and target lesion revascularization, were assessed. Th...
Source: Heart and Vessels - Category: Cardiology Source Type: research
Chronic thromboembolic pulmonary hypertension (CTEPH) is a severe but potentially treatable cause of pulmonary hypertension, which is characterized by remodelling of the pulmonary arteries due to persistent occlusion of large and medium sized pulmonary arteries by highly adherent, organized thrombi. Inadequate clearance of thrombi can lead to small-vessel disease through unresolved thrombi, altered blood flow, and proliferative remodeling.1 Prognosis is poor without treatment, and pulmonary endarterectomy is well established as the definitive and potentially curative treatment method for CTEPH;2 however, in patients with d...
Source: Clinical Radiology - Category: Radiology Authors: Tags: Commentary Source Type: research
CONCLUSION: Our results indicate that DCB angioplasty is associated with significantly improved patency in the treatment of restenosis in radiocephalic AVFs. A longer follow-up or randomized controlled trial is warranted. PMID: 30897933 [PubMed - as supplied by publisher]
Source: Acta Radiologica - Category: Radiology Authors: Tags: Acta Radiol Source Type: research
ConclusionAcute limb ischemia caused by an EXOSEAL vascular closure device is a very rare complication. Balloon angioplasty and stenting are considered to be effective options to deal with the plug dislodgement of an EXOSEAL vascular closure device. We must be prepared for every rare complication during endovascular treatment.
Source: Journal of Medical Case Reports - Category: General Medicine Source Type: research
Following its first successful use in re-opening an artery with stenosis by Dr. Andreas Gr üntzig in 1974,1 balloon catheter was applied to not only angioplasty but also dilatation of esophageal strictures under fluoroscope in two adults in 1981 and under fiberesophagoscope in seven patients, including a child with caustic stricture complicated twice with perforation in 1984.2,3 Balloon catheters can pass thorough severe, lengthy, irregular esophageal strictures with a bendable guide wire with subsequent balloon catheter dilatation for patients who had failed treatment with conventional bougienage techniques.
Source: Pediatrics and Neonatology - Category: Perinatology & Neonatology Authors: Tags: Editorial Source Type: research
AbstractObjectivesChronic thromboembolic pulmonary hypertension (CTEPH) can be treated with balloon pulmonary angioplasty (BPA) in inoperable patients. Sensitive non-invasive imaging methods are missing to detect treatment response after a single BPA treatment session. Therefore, the aim of this study was to measure treatment response after a single BPA session using cardio-pulmonary MRI.Materials and methodsOverall, 29 patients with CTEPH were examined with cardio-pulmonary MRI before and 62 days after their initial BPA session. Pulmonary blood flow (PBF), first-pass bolus kinetic parameters, and biventricular mass and fu...
Source: European Radiology - Category: Radiology Source Type: research
To evaluate the feasibility of two-dimensional parametric parenchymal blood flow (2D-PPBF) to quantify perfusion changes in the lung parenchyma following balloon pulmonary angioplasty (BPA) for treatment of chronic thromboembolic pulmonary hypertension.
Source: Clinical Radiology - Category: Radiology Authors: Source Type: research
Paclitaxel drug-coated balloons and drug-eluting stents received some bad press in January after a meta-analysis showed an increased risk of death for patients treated with these devices in the femoral and/or popliteal arteries of the lower limbs. Two drug-eluting device trials were paused after the analysis was published in the Journal of the American Heart Association and the data prompted FDA to investigate. Mike Matson, a medtech analyst at Needham &Co., issued a report in February pointing to evidence and expert opinion that the benefits of using paclitaxel balloons and stents outweigh the risks. Now, ...
Source: MDDI - Category: Medical Devices Authors: Tags: Cardiovascular Source Type: news
Drug coated balloons (DCB) improve the patency of femoropopliteal angioplasty but their use in infrapopliteal lesions is debateable as paclitaxel (PTX) particle embolisation has been suspected in some trials. The aim of this study was to compare experimentally five DCBs in terms of distal embolism of PTX.
Source: European Journal of Vascular and Endovascular Surgery - Category: Surgery Authors: Source Type: research
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