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Meta-analysis: Drug-coated devices show comparable aggregate outcomes to non-drug-coated devices in CLTI
Drug-coated balloon (DCB) angioplasty appears to offer similar benefits as plain old balloon angioplasty (POBA), with or without stenting, for patients with chronic limb-threatening ischemia (CLTI) who are undergoing endovascular femoropopliteal segment lower extremity revascularization, according to new meta-analysis data…
‘We need to look at the totality of evidence’: VIVA panelists examine SWEDEPAD findings
A focused session at the 2025 Vascular Interventional Advances (VIVA) conference (2–5 November, Las Vegas, USA) homed in on the latest findings from the SWEDEPAD registry-based randomized controlled trials (RCTs), with panelists discussing the results with reference to the wider…
SWEDEPAD re-opens paclitaxel safety discussion, finds drug-coated devices do not improve outcomes
Drug-coated balloons and stents were not associated with reduced risk of amputation or improved quality of life compared with uncoated devices in the SWEDEPAD 1 and 2 trials. In addition, higher five-year mortality with drug-coated devices in patients with intermittent…
Study finds adverse outcomes after decreased use of paclitaxel-coated devices
A recent analysis of over 270,000 Medicare fee-for-service beneficiaries has found an increase in adverse outcomes and death after a US Food and Drug Administration (FDA) warning led to decreased use of paclitaxel-coated devices for peripheral revascularisation procedures. Writing in…
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 this morning’s Peripheral Arterial Controversies programme. Among several presentations on paclitaxel safety, he reported that: yes,…
UK MHRA update: Paclitaxel-coated device increased mortality risk is withdrawn for PAD
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 can be considered for the treatment of peripheral arterial disease (PAD), including intermittent claudication and critical…
TRANSCEND 36-month data “continue to demonstrate safe and effective performance” of SurVeil DCB
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 November, New York, USA). The TRANSCEND trial is a prospective, multicentre, single-blind randomised controlled trial to…
TCT 2023: First presentation of complete patient-level dataset on paclitaxel and death that helped sway the FDA
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 treat peripheral arterial disease (PAD)—have been made public for the first time at TCT 2023 (Oct.…
TCT 2023: First presentation of complete patient-level dataset on paclitaxel and death that helped sway the US FDA
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 to treat peripheral arterial disease (PAD)—have been made public for the first time at TCT 2023…
Long-awaited FDA update finds data do not support excess mortality risk for paclitaxel-coated devices
[vc_row][vc_column][vc_column_text] In a letter to healthcare providers dated July 11, 2023, the Food and Drug Administration (FDA) communicates that the risk of mortality associated with paclitaxel-coated devices to treat peripheral arterial disease (PAD) is no longer supported based on data…