Is the Paclitaxel Narrative Getting Worse?

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, however, the analyst is shifting his stance on the issue. "Recent developments seem to have created more uncertainty," Matson said in a March 12 note. "Data corrections by Cook Medical and Medtronic aren't helping the paclitaxel narrative, in our view." Medtronic reported in February that there was a programming error in the clinical data reporting isolated to the two- and three-year follow-up periods in the company's IN.PACT global post-market study. The error caused mortality data to be omitted from the summary tables included in the statistical analysis, Medtronic said. The deaths were, however, previously included and reported in Medtronic's database, captured in the appropriate study exit forms, and adjudicated by an independent clinical events committee. Not long after Medtronic reported the error, the journal Circulation reported c...
Source: MDDI - Category: Medical Devices Authors: Tags: Cardiovascular Source Type: news

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Percutaneous transluminal angioplasty (PTA) is increasingly requested in the therapy of peripheral arterial occlusive disease. The evaluation of the technical result after balloon angioplasty with regard to ba...
Source: BMC Medical Imaging - Category: Radiology Authors: Tags: Research article Source Type: research
This study compares the outcomes of atherectomy to percutaneous transluminal angioplasty (PTA) and stenting for treatment of isolated femoropopliteal disease.
Source: Annals of Vascular Surgery - Category: Surgery Authors: Tags: Clinical Research, Basic Science Source Type: research
In this study, we sought to investigate the efficacy of the percutaneous transluminal angioplasty method for the treatment of critical limb ischemia (CLI) in patients with Buerger's disease in our modest cohort. METHODS: Patients diagnosed with CLI secondary to Buerger's disease who underwent percutaneous transluminal angioplasty between May 2014 and June 2017 were retrospectively investigated. Patient demographics, presentations, procedural details, responses to percutaneous treatment, complications, limb salvage, wound healing, reinterventions, and early follow-up data were recorded. RESULTS: The cohort included ...
Source: The Journal of Invasive Cardiology - Category: Cardiology Tags: J Invasive Cardiol Source Type: research
Condition:   Peripheral Artery Disease Intervention:   Device: AcoArt Orchid (0.035 " ), AcoArt Tulip (0.018 " ) and AcoArt Litos (0.014 " ) percutaneous transluminal angioplasty (PTA) paclitaxel drug coated balloon catheter manufactured by Acotec Scientific Co., Ltd. Sponsor:   Acotec Scientific Co., Ltd Not yet recruiting
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
AbstractCholesterol crystal embolization (CCE) is a rare, mainly iatrogenic condition. The proportion of CCE after cardiovascular procedures has not been fully elucidated. The purpose of this study was to determine the proportion of CCE diagnosed after cardiovascular procedures and to identify risk factors for CCE occurrence. Data on patients aged older than 40  years who underwent cardiovascular procedures between July 2010 and March 2017 were extracted from the Japanese Diagnosis Procedure Combination database. Inpatients diagnosed with CCE within 1 year after procedures in the same hospital were identified. Lo...
Source: Heart and Vessels - Category: Cardiology Source Type: research
The aim was to review and analyse the literature on clinical outcomes of drug coated balloon (DCB) vs. standard percutaneous transluminal angioplasty (PTA) for the treatment of infrapopliteal arterial disease.
Source: Journal of Vascular Surgery - Category: Surgery Authors: Source Type: research
To ascertain the safety and mid-term outcomes of RotarexS rotational atherectomy plus thrombectomy device (Straub Medical AG, Wangs, Switzerland) with or without adjunctive treatment (e.g., percutaneous transluminal angioplasty, PTA/Drug-coated balloon, DCB/stenting) in patients with in-stent restenosis (ISR) or occlusion in the iliac and/or infrainguinal arteries.
Source: Journal of Vascular and Interventional Radiology : JVIR - Category: Radiology Authors: Tags: Scientific Session 34 Source Type: research
Authors: Nassar GM, Beathard G, Nguyen DT, Graviss EA Abstract INTRODUCTION: Percutaneous balloon angioplasty of arteriovenous fistula-associated stenosis is performed for a variety of indications. Successful percutaneous transluminal angioplasty (PTA) is expected to increase in arteriovenous fistula blood flow rate (Qa). A validated approach to predicting changes in Qa based upon stenosis characteristics is not available. METHODS: Three baseline parameters were determined in a group of patients with a single arteriovenous fistula-associated stenosis undergoing PTA. These were percent estimated stenosis, stenos...
Source: The Journal of Vascular Access - Category: Surgery Tags: J Vasc Access Source Type: research
Device profile of different paclitaxel-coated balloons: Neuro Elutax SV, Elutax "3" Neuro and SeQuent Please NEO for the treatment of symptomatic intracranial high-grade stenosis: overview of their feasibility and safety. Expert Rev Med Devices. 2020 Jan 21;: Authors: Gruber P, Remonda L Abstract Introduction: Intracranial atherosclerotic disease (ICAD) is highly prevalent and probably the most common cause of stroke worldwide. Despite best medical treatment (BMT), the rate of recurrent stroke in symptomatic ICAD patients is elevated, especially in those with high-grade stenosis. Thus, altern...
Source: Expert Review of Medical Devices - Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research
The aim was to review and analyse the literature on clinical outcomes of drug coated balloon (DCB) vs. standard percutaneous transluminal angioplasty (PTA) for the treatment of infrapopliteal arterial disease.
Source: European Journal of Vascular and Endovascular Surgery - Category: Surgery Authors: Tags: Systematic Review Source Type: research
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