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‘Proceed cautiously in use of DCBs in CLTI patients with advanced WIfI stage’
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 disease (PAD). The latest contribution from Konstantinos Katsanos, MD, and colleagues raises questions about potential increased…
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 [PCBs] in the lower-limb arteries: A systematic review and meta-analysis of randomized controlled trials [RCTs],” published in…
European launch: Medtronic receives CE mark for 200mm and 250mm IN.PACT Admiral DCBs
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 complex femoropopliteal lesions efficiently in patients with peripheral arterial disease (PAD). The 200mm and 250mm IN.PACT Admiral…
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 radiologist Konstantinos Katsanos, MD, that reported a heightened risk of major amputation after use of paclitaxel-coated balloons…
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 at the University of California San Francisco, told delegates attending the International Symposium on Endovascular Therapy…
FDA panel recommends against premarket approval of Lutonix 014 DCB for BTK use
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. In a meeting on Feb. 17, the majority of the FDA Cardiovascular Devices Panel concluded that…
Veterans study: No evidence of increased risk of death with use of PCDs out to three years
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 two‐ and three‐year all‐cause mortality were similar among patients undergoing revascularization with a paclitaxel-coated device (PCD)…
LINC 2021: Long-term data show sustained efficacy and safety of paclitaxel devices in fempop lesions
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 emergence of long-term evidence on paclitaxel devices in the femoropopliteal segment. Results out to five years shows…
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 with the Stellarex drug-coated balloon (DCB) and those treated with percutaneous transluminal angioplasty (PTA), the current standard…
FDA representatives respond to SWEDEPAD interim analysis, highlight need for continued study
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 patients with peripheral arterial disease (PAD) received treatment with paclitaxel-coated or uncoated endovascular devices. However, writing in…