Tag: paclitaxel
Paclitaxel controversy: Yes, device restrictions did cause harm
“Unfortunately, we are doing worse for our patients today,” were the sobering thoughts of Eric Secemsky (Boston, United States) during a late-breaking presentation in...
UK MHRA update: Paclitaxel-coated device increased mortality risk is withdrawn for...
Following a review, the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA) has updated guidance on the use of paclitaxel-coated devices stating that such devices...
TRANSCEND 36-month data “continue to demonstrate safe and effective performance” of...
Peter Schneider (University of California San Francisco, San Francisco, USA) recently presented 36-month data from Surmodics' TRANSCEND clinical trial at the VEITHsymposium 2023 (14–18...
Vascular Specialist–November 2023
In this issue:
Carotid revascularization: Getting to the right decision
SVS reveals proposed changes to Society bylaws
Meta-analysis: The complete patient-level dataset on paclitaxel and...
TCT 2023: First presentation of complete patient-level dataset on paclitaxel and...
Data from a patient-level meta-analysis—a factor in the Food and Drug Administration’s (FDA) recent change of position on the use of paclitaxel-coated devices to...
TCT 2023: First presentation of complete patient-level dataset on paclitaxel and...
Data from a patient-level meta-analysis—a factor in the US Food and Drug Administration’s (FDA) recent change of position on the use of paclitaxel-coated devices...
Vascular Specialist–August 2023
In this issue:
SVS responds to New York Times exposé on overuse of vascular interventions
Long-awaited FDA update finds data do not support excess...
Long-awaited FDA update finds data do not support excess mortality risk...
In a letter to healthcare providers dated July 11, 2023, the Food and Drug Administration (FDA) communicates that the risk of mortality associated with...
New long-term data of paclitaxel devices continue to show no increased...
New long-term data from the SAFE-PAD (Safety assessment of femoropopliteal endovascular treatment with paclitaxel-coated devices) study were presented today as late-breaking clinical research at...
Tissue samples show paclitaxel effect in minority of CLTI patients receiving...
Paclitaxel effect was witnessed in tissue specimens of a minority of chronic limb-threatening ischemia (CLTI) patients treated with drug-coated balloons (DCBs)—but was not dependent...
New sirolimus data provide encouragement despite ‘potentially disappointing’ efficacy results
The results of a small-scale pilot study from Asia have indicated “potentially disappointing” results with a novel drug-eluting balloon in treating dysfunctional arteriovenous access...
Medtronic issues voluntary recall for subset of IN.PACT Admiral and IN.PACT...
Medtronic recently voluntarily recalled a subset of its IN.PACT Admiral and IN.PACT AV paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon catheters due to the potential...
‘Proceed cautiously in use of DCBs in CLTI patients with advanced...
The last several years have seen ongoing controversy and debate about the risks and benefits of paclitaxel-coated devices (PCDs) for patients with peripheral arterial...
PCBs: Panel of vascular surgeons review latest findings on paclitaxel-coated balloons
A recent meta-analysis by Konstantinos Katsanos, MD, of Patras University Hospital, Rion, Greece, and colleagues—“Risk of major amputation following application of paclitaxel-coated balloons ...
VAM discussion on latest paclitaxel meta-analysis yields mix of caution, skepticism
A Vascular Annual Meeting (VAM) sponsored session on paclitaxel safety drew a mix of skeptical and cautious responses to the latest meta-analysis from interventional...
VAM: Industry-sponsored symposia
Industry-sponsored symposia at the Vascular Annual Meeting (VAM) will be presented Wednesday and Thursday evenings and at three breakfast sessions taking place Thursday morning....
The top 10 most popular Vascular Specialist stories in July
The digital version of our July 2021 print issue, an argument in favor of a multidisciplinary approach to limb salvage and look back at...
ACC.21: SAFE-PAD finds no increased risk of death with drug-coated devices
Researchers have found no statistically significant difference in mortality between patients treated with drug-coated devices and non-drug-coated devices in the SAFE-PAD study. Eric Secemsky,...
Innovation: ISET audience hears what’s on the horizon for CLTI patients
“I am going to give you reasons to be excited about your critical limb practice,” Peter Schneider, MD, professor of vascular and endovascular surgery...
FDA representatives respond to SWEDEPAD interim analysis, highlight need for continued...
Representatives from the Food and Drug Administration (FDA) referenced "important and reassuring" results from the recent interim analysis of the SWEDEPAD clinical trial in which...
SWEDEPAD unplanned interim analysis shows no difference in all-cause mortality for...
An unplanned interim analysis of the registry-based SWEDEPAD clinical trial, in which patients with peripheral arterial disease (PAD) received treatment with paclitaxel-coated (drug-coated balloons...
New analysis finds DCBs lead to greater four-year survival after fempop...
Patients treated with a paclitaxel-coated balloon saw greater survival, freedom from amputation and amputation-free survival through four-year follow-up after their initial femoropopliteal revascularization operation...
TCT 2020 late-breaking trials session features new data on drug-coated devices
Findings from a series of late-breaking trials in the endovascular field were delivered recently at TCT Connect (Oct. 14–18), the 32nd annual scientific symposium...
Vascular surgeons encouraged to consult talking points document on paclitaxel devices
Vascular surgeons are being encouraged to take consideration of a set of talking points about the risks and benefits of paclitaxel-equipped devices—which has been...
IN.PACT Admiral DCB shows ‘significant advantage’ over uncoated devices in fempop...
The IN.PACT Admiral drug-coated balloon (DCB) demonstrated a significant advantage in overall survival, amputation-free survival and target-lesion revascularization after femoropopliteal artery treatment through four-year...
September slate of regional vascular meetings goes digital
This time last year, the ranks of vascular surgery were gearing up to head for points East, West, Midwest and Northeast as the slew...
High level of heterogeneity found in randomized PAD trial antithrombotic regimens
A recent systematic review showed that randomized trials comparing different types of peripheral endovascular arterial intervention have a high level of heterogeneity in their...
Six-month IN.PACT AV Access results show superiority of DCB angioplasty
Just-published six-month results of the IN.PACT AV Access study show that drug-coated balloon (DCB) angioplasty is superior to standard angioplasty for the treatment of...
MHRA: Warning to be added to paclitaxel device IFUs in Europe
In a new field safety notice, the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) states that a warning and clinical summary section will be...
CX 2020 LIVE pioneers virtual vascular conference format in COVID-19 era
CX 2020 LIVE came to life online—despite COVID-19—using state-of-the art broadcast technology to bring together more than 1,000 vascular specialists, live, from 95 countries across...
FDA official delivers government agency’s early reaction to latest contentious meta-analysis...
HOLLYWOOD, Fla.—A Food and Drug Administration (FDA) official delivered a talk which represents the government agency’s earliest public reaction to the latest meta-analysis suggesting...
Deploying robust, detailed SVS VQI data to help better define role...
In December 2018, the Journal of the American Heart Association published “Risk of death following application of paclitaxel‐coated balloons and stents in the femoropopliteal...
New meta-analysis finds ‘no observed difference’ in mortality between paclitaxel and...
February 2020 brings another paclitaxel device meta-analysis of randomized controlled trials in chronic limb-threatening ischemia (CLTI) patients. Krystal Dinh, BMed, of Westmead Hospital, Sydney,...
SVS president presents point-by-point defense of Society position on paclitaxel controversy
NEW YORK—Kim Hodgson, MD, president of the Society for Vascular Surgery, delivered a robust defense of the SVS position on the drug-coated balloon (DCB)...
Hotly-contested meta-analysis suggests a higher risk of death or amputation at...
A new meta-analysis, just published in the Journal of Vascular and Interventional Radiology (JVIR), suggests significantly reduced amputation-free survival at one year when paclitaxel-coated...