FDA grants R3 Vascular IDE approval for ELITE-BTK pivotal trial of Magnitude drug-eluting bioresorbable scaffold

R3 Vascular today announced that the Food and Drug Administration (FDA) has granted investigational device exemption (IDE) approval to initiate its ELITE-BTK pivotal trial of the next-generation Magnitude drug-eluting bioresorbable scaffold for below-the-knee (BTK) peripheral arterial disease (PAD). “We are…
TCT 2024: Drug-eluting resorbable scaffold proves cost effective at one year in LIFE-BTK analysis

A retrospective economic analysis of the LIFE-BTK trial has demonstrated the one-year cost-effectiveness of an everolimus-eluting resorbable scaffold over angioplasty for the treatment of infrapopliteal artery disease, with investigators predicting more significant results in the longer term. Sharing this finding…
CMS grants transitional pass-through payment for Medtronic’s Symplicity Spyral and Recor’s Paradise renal denervation systems

The Centers for Medicare and Medicaid Services (CMS) has granted transitional pass-through (TPT) payment for Medtronic’s Symplicity Spyral renal denervation (RDN) catheter and Recor Medical’s Paradise ultrasound RDN (uRDN) system, according to press releases from the two companies. TPT payment,…
Endoscopic vein harvest under the microscope

Conflicting results open fresh debate around effect of vein harvesting technique on long-term patency of lower extremity bypass grafts. Two separate analyses that looked at the impact made by the method used to harvest great saphenous vein (GSV) on the…
VAM 2025 abstract submission period set to open Nov. 6

Vascular surgeon-scientists may submit their research for presentation at the 2025 Vascular Annual Meeting (VAM) in June starting from Nov. 6 through Wednesday, Jan. 8, 2025. VAM research—both clinical and translational—is considered for presentation in several different forums that appeal…
Former SVS president named ACS president-elect

The American College of Surgeons (ACS) elected Anton N. Sidawy, MD, as president-elect during the ACS annual business meeting on Oct. 22. He served as president of the Society for Vascular Surgery (SVS) in 2010. Sidawy is currently the Lewis…
Surmodics announces early results from PROWL registry of Pounce thrombectomy system

Surmodics has announced that early results of a subset of 60 real-world acute, subacute, and chronic limb ischaemia patients from its PROWL registry study were presented by Dean Ferrera (Powers Health, Munster, USA) at TCT 2024 (27–30 October, Washington, DC,…
The Japanese concept of ikigai and how mentorship might help specialty amid challenges of vascular surgery workforce shortage

The Japanese concept of ikigai, or an individual’s reason for being, underpinned the message behind a fresh call for mentorship in vascular surgery and how mentoring could aid efforts to plug a shortage in the specialty’s workforce. Roy M. Fujitani,…
TCT 2024: PEERLESS trial finds large-bore mechanical thrombectomy superior for intermediate-risk PE

Findings from the first international randomised controlled trial (RCT) to compare patient outcomes following treatment with large-bore mechanical thrombectomy (LBMT) versus catheter-directed thrombolysis (CDT) for intermediate-risk pulmonary embolism (PE) found that LBMT is superior with respect to the hierarchically-tested aggregated…
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…

