Tag: DCBs

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...
Richard Neville

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)...