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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…
FDA grants approval for IDE study on Advance Evero 18 everolimus-coated balloon catheter
The Food and Drug Administration (FDA) has granted approval for Cook Medical to initiate an investigational device exemption (IDE) study on the Advance Evero 18 everolimus-coated percutaneous transluminal angioplasty (PTA) balloon catheter, the company reported today. The clinical study…
TCT 2024: One-year data from SIRONA trial show similar results for sirolimus versus paclitaxel DCB
Data from the prospective, multicentre, investigator-initiated SIRONA randomised clinical trial demonstrated MagicTouch (Concept Medical) sirolimus-coated balloons to be noninferior compared to paclitaxel-coated balloons with regards to the primary safety and efficacy endpoints in patients with femoropopliteal artery disease. Findings were…
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,…
The top 10 most popular Vascular Specialist stories of November 2023
In November, the most read stories from Vascular Specialist include a reassessment of which carotid revascularization treatment modality is best after the recent Centers for Medicare & Medicaid Services (CMS) coverage expansion; updated analyses from the VOYAGER PAD clinical trial;…
Two-year SWING data ‘continue to show promise’ for sirolimus DCB in treating BTK disease
Two-year data from the SWING trial, a first-in-human study of the safety and performance of the Sundance sirolimus drug-coated balloon (DCB; Surmodics), have been presented at this year’s VEITHsymposium (Nov. 14–18) in New York City. The SWING trial is a…
Popliteal artery lesions: Two-year results from European DCB catheter registry announced
“We face a scarcity of data evaluating endovascular therapy for isolated popliteal artery lesions, known as a difficult vessel bed to treat as we don’t want to leave anything behind,” said Frank Vermassen, MD, chief of vascular and thoracic surgery…
Light-activated drug-coated balloon granted FDA approval for clinical study
Alucent Biomedical has announced that the Food and Drug Administration (FDA) granted an investigational device exemption (IDE) for a U.S. clinical study of AlucentNVS, a light-activated, drug-coated balloon catheter technology. AlucentNVS combines an intravascular device with a photochemical process to…
Surmodics receives FDA approval for the SurVeil drug-coated balloon
Surmodics has announced the receipt of Food and Drug Administration (FDA) approval for the SurVeil drug-coated balloon (DCB). A company press release notes that the SurVeil DCB may now be marketed and sold in the U.S. to physicians for percutaneous…
Surmodics provides regulatory update related to FDA premarket approval application for SurVeil
Surmodics recently announced it has received a letter from the Food and Drug Administration (FDA) related to its premarket approval (PMA) application for the SurVeil drug-coated balloon (DCB). In the letter, the FDA indicated that the application is not currently…