PATHFINDER I Registry Will Study AngioDynamics’ Auryon Atherectomy System
January 16, 2020—AngioDynamics, Inc. announced the launch of the PATHFINDER I postmarket registry, which will enroll a total of 100 patients with peripheral artery disease (PAD) treated with the company’s Auryon atherectomy system in a postmarket setting with 36-month follow-up.
Continuing Coverage: Paclitaxel In PAD
New Paclitaxel Meta-Analysis Questions Safety in CLI Population; Concerns Voiced as to Methods
January 15, 2020—In the wake of a year spent scrutinizing the finding of a mortality signal related to paclitaxel-coated balloons and stents in the superficial femoral artery (SFA), a new publication again calls the safety of paclitaxel into question, only this time in the critical limb ischemia (CLI) population.
Continuing Coverage: Paclitaxel In PAD
German Analysis Shows Long-Term Survival With Paclitaxel-Coated Devices Used for Femoropopliteal Artery Revascularization
January 13, 2020—The rapid adoption of the use of paclitaxel-coated devices to treat patients with chronic limb-threatening ischemia (CLTI) has resulted in higher long-term survival, better amputation-free survival, and lower rates of major cardiovascular events, concluded investigators of a retrospective, propensity score-matched cohort analysis of German health insurance claims.
Enrollment Completed in PRESTIGE BTK Trial of MedAlliance’s Selution SLR Device
January 10, 2020—MedAlliance announced the completion of patient enrollment in the PRESTIGE below-the-knee clinical trial, which is evaluating the 6-month safety and performance outcomes of the company’s Selution SLR sirolimus-eluting balloon catheter for the treatment of long tibial occlusive lesions (TASC C & D) in patients with critical limb ischemia.
Infrapop‐CTO Score Developed to Predict Success of Anterograde Crossing in CLI Patients
January 7, 2020—The development and validation of the Infrapop‐CTO Score, a predictive score for anterograde crossing of infrapopliteal chronic total occlusions (CTOs), were described in an article published by Damianos G. Kokkinidis, MD, et al in Catheterization & Cardiovascular Interventions.
ESVS Publishes 2020 Clinical Practice Guidelines on the Management of Acute Limb Ischemia
January 7, 2020—The European Society for Vascular Surgery (ESVS) announced the publication of the “ESVS 2020 Clinical Practice Guidelines on the Management of Acute Limb Ischemia” online ahead of print in European Journal of Vascular & Endovascular Surgery (EJVES) by Martin Björck, MD, et al.
Randomized Controlled Trial Compares Nitinol Stents Versus Bypass in Long Femoropopliteal Lesions
December 13, 2019—Investigators from Paracelsus Medical University in Salzburg, Austria, conducted a study that sought to compare patency rates and clinical outcomes of endovascular therapy using nitinol stents and primary vein bypass in long femoropopliteal lesions.
First Patient Enrolled in LimFlow’s PROMISE II United States Pivotal Study
December 10, 2019—LimFlow SA announced that the first patient has been treated in PROMISE II, the company’s United States pivotal trial of the LimFlow percutaneous deep vein arterialization (pDVA) system for the treatment of chronic limb-threatening ischemia (CLTI).
European Societies Publish Consensus Document on Follow-Up After Revascularization for PAD
November 14, 2019—A consensus document from European societies on the follow-up of patients after revascularization for peripheral artery disease (PAD) was published by Maarit Venermo, MD, et al in the European Journal of Vascular and Endovascular Surgery (2019;58:641–653).
Study Supports ≥ 6 Months of DAPT After Endovascular Revascularization for Lower Extremity PAD
November 13, 2019—Sungsoo Choo, MD, et al published findings from an investigation to determine the optimal strategy for antiplatelet therapy in patients who have undergone endovascular revascularization for lower extremity peripheral artery disease (PAD).
Early Outcomes Presented for Inari's ClotTriever System to Treat DVT
November 6, 2019—Inari Medical, Inc. announced the presentation of early outcomes from CLOUT, the ClotTriever Outcomes Registry evaluating the company’s ClotTriever mechanical thrombectomy system for treatment of acute and chronic lower extremity deep vein thrombosis (DVT).
Five-Year Results From ABSORB BTK Trial Presented
November 6, 2019—The 5-year results of the ABSORB BTK trial—a prospective, nonrandomized, single-center study evaluating a novel bioresorbable, drug-eluting scaffold for the treatment of peripheral artery disease below the knee—were presented by Ramon L. Varcoe, MBBS, MS, PhD, during a late-breaking clinical trial session at VIVA 2019, the Vascular InterVentional Advances meeting held November 4–7 in Las Vegas, Nevada. Prof. Varcoe is Associate Professor of Vascular Surgery at the University of New South Wales in Sydney, Australia.
Twelve-Month Outcomes Presented From Mercator MedSystems' TANGO Trial
November 6, 2019—VIVA Physicians announced the presentation of initial 12-month outcomes of the TANGO trial , a phase 2, dose-escalation, double-blinded trial comparing the delivery of temsirolimus versus saline in patients with severe claudication or critical limb ischemia, with the purpose of limiting neointimal hyperplastic tissue growth into the artery after endovascular below-the-knee (BTK) revascularization procedures.
DISAPEAR Registry Evaluates Abbott's Absorb BVS in Asian Cohort With CLTI
November 6, 2019—One-year results from the DISAPEAR registry evaluating the Absorb bioresorbable vascular scaffold (BVS; Abbott) were presented by Steven Kum, MD, in a late-breaking clinical trial session at VIVA 2019, the Vascular InterVentional Advances meeting held November 4–7 in Las Vegas, Nevada.
ULYSSE Registry Data Suggest Ultrasoundplasty Before Angioplasty for BTK Lesions May Improve Outcomes
November 6, 2019—Costantino Del Giudice, MD, presented data from the ULYSSE registry during a late-breaking clinical trial session at VIVA 2019, the Vascular InterVentional Advances meeting held November 4–7 in Las Vegas, Nevada.
Six-Month Data From Intact Vascular TOBA II BTK Trial Presented
November 6, 2019—Intact Vascular, Inc. announced that the 6-month results of its Tack Optimized Balloon Angioplasty (TOBA) II below-the-knee (BTK) clinical trial achieved all primary (P < .0001) and secondary endpoints with very low rates of major amputation and all-cause death.
Sponsored by Boston Scientific Corporation
May 2019 Supplement
US Device Guide
This Device Guides offers a searchable, comprehensive listing of the available vascular interventional devices in the United States.
European Device Guide
This Device Guides offers a searchable, comprehensive listing of the available vascular interventional devices in Europe.