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Potential ‘new paradigm’ in treatment of long occlusive lesions emerges
Vascular surgeon Lewis Schwartz, MD, has had an interest in biomedical engineering since very early in his career. So his involvement in the early-stage Efemoral vascular scaffold system marks a significant milestone in a mission to save legs and provide…
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…
PRISTINE registry with Selution SLR sirolimus drug-eluting balloon completes enrollment
MedAlliance has announced completion of patient enrollment in the PRISTINE clinical trial with the Selution SLR 018 drug-eluting balloon (DEB) for the treatment of patients with below-the-knee (BTK) disease. According to a MedAlliance press release, Selution SLR is the first DEB to be…
Postmarket study of sirolimus-eluting balloon enrolls first patient
MedAlliance has announced enrollment of the first patient in SUCCESS PTA, its large post-market study with the drug-eluting balloon Selution SLR for the treatment of patients with peripheral arterial disease (PAD). Selution SLR is a novel sirolimus-eluting balloon that provides…
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)…
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 added to the instructions for use (IFU) of 12 paclitaxel-coated balloons and paclitaxel-eluting stents used in…
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 (Jan. 8–11) in Palm Beach, Florida. William P. Robinson III, MD, professor and chief in the…