Tag: DCBs
New analysis: Four multicenter trials support primary use of drug-coated balloons...
A patient-level, propensity-adjusted comparison of three-year results from a quartet of prospective, multicenter trials support the primary use of drug-coated balloons (DCBs) versus bare...
Selution SLR receives second FDA IDE approval
Selution SLR, MedAlliance’s sirolimus-eluting balloon, has received conditional Food and Drug Administration (FDA) investigational device exemption (IDE) approval to initiate its pivotal clinical trial...
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...
CX 2022: IN.PACT AV DCB shows sustained and superior performance compared...
New randomized controlled data demonstrating the sustained and superior performance of IN.PACT AV drug-coated balloons (DCBs) compared to percutaneous transluminal angioplasty (PTA) through 36...
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...
IN.PACT Admiral DCB performs well across wide range of clinical, anatomical...
In a pooled analysis of the predictors of drug-coated balloon (DCB) effectiveness, the IN.PACT Admiral DCB (Medtronic) performed well across a broad range of clinical, anatomical...
The top 10 most popular Vascular Specialist stories in September
Five-year data from the ACST-2 trial comparing carotid endarterectomy and carotid artery stenting, a report from the Crawford Forum at the 2021 Vascular Annual...
IN.PACT AV DCB sustained ‘superior’ effectiveness in subgroups with high reintervention...
Several subgroups of patients treated with the IN.PACT AV drug-coated balloon (DCB) for arteriovenous fistulas (AVFs) demonstrated a “statistically significant” higher rate of target...
Two-year Ranger DCB data demonstrate ‘sustained, high rate’ of device efficacy
Patients treated with Boston Scientific’s Ranger drug-coated balloon (DCB) sustained “improved primary patency” with fewer reinterventions than those treated with uncoated devices, two-year results...
‘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 ...
European launch: Medtronic receives CE mark for 200mm and 250mm IN.PACT...
Medtronic has announced the European launch of the 200mm and 250mm IN.PACT Admiral drug-coated balloons (DCBs) following CE mark approval. The product is intended to treat long...
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...
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 panel recommends against premarket approval of Lutonix 014 DCB for...
A Food and Drug Administration (FDA) advisory panel has recommended against premarket approval of BD’s Lutonix 014 drug-coated balloon (DCB) for use in below-the-knee (BTK) arteries....
Veterans study: No evidence of increased risk of death with use...
A study of more than 10,000 U.S. veterans with peripheral arterial disease (PAD) undergoing endovascular interventions in the femoropopliteal segment found that rates of...
LINC 2021: Long-term data show sustained efficacy and safety of paclitaxel...
A key theme among the late-breaking trial data presented at the recent LINC 2021 (the Leipzig Interventional Course), held digitally from Jan. 25–29, was the...
Five-year ILLUMENATE results confirm safety profile of Philips Stellarex DCB
Royal Philips has announced the final, five-year results of two randomized controlled trials (RCTs) that show no difference in all-cause mortality between patients treated...
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...
‘No signal of increased risk of long-term mortality’ with paclitaxel-coated Luminor...
An ad hoc, two-year analysis of the EffPac study found no signal of increased risk of long-term mortality, nor any adverse events, within two years...
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...
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...
Drug-coated technology question aired during SAVS opening session
PALM BEACH, Fla.—Discussion of the drug-coated technology issue was piqued during the opening session of the Southern Association for Vascular Surgery (SAVS) annual meeting...
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)...