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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Cook Medical recalled certain lots of a balloon catheter used for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries after receiving multiple complaints of balloons bursting below the rated burst pressure. The company has determined that the problem affects the Advance Enforcer 35 Focal Force PTA Balloon Catheters manufactured with specific balloon material lots manufactured between October 3, 2018, and December 17, 2018. The recall affects about 33 devices that were distributed to the U.S. market between October 29, 2018, to March 21, 2019, FDA said.Â&nb...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news
Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/135cm, Catalog Number ASB5-35-135-6-4, REF Number G35252 Product Usage: The Advance Enforcer 35 Focal-Force PTA Balloon Catheter is intended for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral, as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the cerebral or coronary vasculature.
Source: Medical Device Recalls - Category: Medical Devices Source Type: alerts
CONCLUSIONS: There are major limitations in the current state of evidence guiding treatment decisions in CLTI, particularly for severe anatomic patterns of disease treated via endovascular means. Periprocedural (30-day) mortality, amputation, and major adverse cardiac events are broadly similar across modalities. Patency rates are highest for saphenous vein bypass, whereas both patency and limb salvage are markedly inferior for prosthetic grafting to below the knee targets. Among endovascular interventions, percutaneous transluminal angioplasty and drug-eluting stents appear comparable for focal infrapopliteal di...
Source: PubMed: Eur J Vasc Endovasc ... - Category: Surgery Authors: Tags: Eur J Vasc Endovasc Surg Source Type: research
INFLAMMATORY RESPONSE FOLLOWING PERIPHERAL ENDOVASCULAR TREATMENT CORRELATES WITH THE EXTENT OF PERIPROCEDURAL ARTERIAL INJURY. Acta Clin Croat. 2018 Dec;57(4):630-637 Authors: Turk T, Rubin O, Šarić G, Mišević T, Kopačin V, Kovač D, Ivković V, Farkaš V, Šerić V Abstract - The aim was to examine whether the postprocedural change in C-reactive protein (CRP) and fibrinogen levels was associated with the extent of periprocedural arterial injury caused by endovascular treatment (EVT). The study recruited 71 patients undergoing EVT. Eighty-four patients that underwent angio...
Source: Acta Clinica Croatica - Category: General Medicine Tags: Acta Clin Croat Source Type: research
Authors: Spiliopoulos S, Karamitros A, Reppas L, Brountzos E Abstract Introduction: Percutaneous transluminal angioplasty (PTA) currently remains the endovascular treatment of choice in a large percentage of patients suffering from peripheral artery disease (PAD). However, the mechanism of angioplasty itself can cause some extent of arterial dissection leading to early vessel restenosis/reocclusion. Current endovascular imaging studies have reported a higher rate of arterial dissection than previously reported in literature and advocated the correlation of dissection with poor patency. Thus, there is the need of de...
Source: Expert Review of Medical Devices - Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research
CONCLUSION: Stent insertion can be considered when fibrotic changes are expected due to repeated inflammation and when the balloon size to be used is small. Balloon angioplasty seems less risky for anastomotic ruptures in portal vein stenosis in the early post liver transplantation period. PMID: 31063137 [PubMed - as supplied by publisher]
Source: Diagnostic and Interventional Radiology : The Turkish Society of Radiology - Category: Radiology Authors: Tags: Diagn Interv Radiol Source Type: research
Conclusion: The segmented sharp recanalization is a practical strategy in treating angled long-segment CVO which is refractory to traditional guide wire transversal in hemodialysis patients.
Source: Medicine - Category: Internal Medicine Tags: Research Article: Clinical Case Report Source Type: research
To assess the efficacy and safety of the LEGFLOW OTW drug coated balloon (DCB; coated with paclitaxel) for the treatment of femoropopliteal artery disease vs. standard percutaneous transluminal angioplasty (PTA) in a Chinese population.
Source: European Journal of Vascular and Endovascular Surgery - Category: Surgery Authors: Source Type: research
CONCLUSION: Results from the RCT showed a superior treatment effect with DCB vs. PTA, with remarkably higher patency and lower CD-TLR rates. These results are consistent with other former DCB trials and demonstrate the safety and efficacy of the LEGFLOW OTW DCB for the treatment of femoropopliteal artery disease. PMID: 30944068 [PubMed - as supplied by publisher]
Source: PubMed: Eur J Vasc Endovasc ... - Category: Surgery Authors: Tags: Eur J Vasc Endovasc Surg Source Type: research
This article has been withdrawn at the request of the author(s) and/or editor. The Publisher apologizes for any inconvenience this may cause.The full Elsevier Policy on Article Withdrawal can be found at
Source: European Journal of Vascular and Endovascular Surgery - Category: Surgery Authors: Source Type: research
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