News | 06.26.20
ILLUMENATE EU RCT Results Evaluate Philips’ Stellarex DCB at 4 Years
June 26, 2020—Royal Philips announced 4-year results from the ILLUMENATE European Randomized Controlled Trial (EU RCT) evaluating the safety and efficacy of Philips’ Stellarex 0.035-inch low-dose drug-coated balloon (DCB) to restore and maintain patency in the superficial femoral artery and popliteal arteries of patients with peripheral artery disease (PAD).
News | 06.25.20
Medicare Advantage Database Analysis Finds No Evidence of Increased Long-Term Mortality After Paclitaxel Device Treatment
June 25, 2020—An analysis of Medicare Advantage patients who underwent femoropopliteal artery revascularization from April 2015 through December 2017 found no evidence of increased long-term mortality in those treated with paclitaxel-based devices, according to new data presented by Eric A. Secemsky, MD, MSc, during a VIVA Late-Breaking Trials Livestream.
News | 06.16.20
Infinity Angioplasty Balloon Catheter Receives 510(k) Clearance
June 16, 2020—Infinity Angioplasty Balloon Co., LLC announced that the FDA has cleared the Infinity angioplasty balloon catheter for percutaneous transluminal angioplasty treatment of peripheral arterial disease in the peripheral vasculature, including iliac, femoral, popliteal, and infrapopliteal arteries, and for the treatment of arteriovenous dialysis fistulas.
News | 06.15.20
European IFUs for Paclitaxel-Coated Devices Will Contain New Warning
June 15, 2020—Manufacturers and marketers of paclitaxel-coated balloons and stents used in the treatment of lower extremity peripheral arterial disease are issuing a Field Safety Notice regarding updates to the indications for use (IFU) for these devices throughout Europe.
News | 06.09.20
Veryan Medical's MIMICS-2 36-Month Data Presented at CX 2020
June 9, 2020—Veryan Medical Ltd., an Otsuka Medical Devices company, announced that the 36-month results from the company's MIMICS-2 study were presented by Professor Thomas Zeller, MD, at CX 2020 Live, the virtual Charing Cross Symposium, which takes place online with programs every Tuesday and Thursday from May 26 to June 25.
News | 06.05.20
BD Launches Halo One Thin-Walled Guiding Sheath
June 5, 2020—BD (Becton, Dickinson and Company) announced the launch of the Halo One thin-walled guiding sheath, which is designed to perform as both a guiding sheath and an introducer sheath for use in peripheral artery and venous procedures requiring percutaneous introduction of intravascular devices.
News | 05.27.20
Enrollment Begins in ACTIVATE I Study of Alucent NVS Vessel Restoration System
May 27, 2020—Alucent Biomedical Inc. announced that it has enrolled the first two patients in ACTIVATE I, a phase 1 clinical trial to evaluate the safety and efficacy of its Natural Vascular Scaffolding (NVS) technology for the treatment of peripheral artery disease (PAD) of the lower extremities.
News | 05.27.20
VIVA's Paclitaxel Analysis Finds Increased Mortality Risk, But No Dose Association; Lead Author Encourages Close Read
May 27, 2020—Earlier this month, VIVA Physicians announced the publication of an analysis of mortality and paclitaxel-coated devices by Krishna Rocha-Singh, MD, et al, which is available online ahead of print in Circulation.
News | 05.13.20
Twelve-Month Data Published From European TOBA III Study of Intact Vascular's Tack Endovascular System
May 13, 2020—Intact Vascular, Inc. announced that the 12-month results from the Tack Optimized Balloon Angioplasty (TOBA) III clinical trial were published by Marianne Brodmann, MD, et al in the Journal of Vascular Surgery.
News | 05.06.20
Getinge Introduces Larger-Diameter Advanta V12 Balloon-Expandable Covered Stent to Treat Iliac Artery Disease
May 6, 2020—Getinge announced the commercial introduction of a larger-diameter Advanta V12 balloon-expandable covered stent, which expands from 12 to 16 mm, to treat iliac arterial occlusive disease.
News | 04.14.20
FDA Approves Intact Vascular's Tack Endovascular System for BTK Dissection Repair
April 14, 2020—Intact Vascular, Inc. announced FDA approval of its Tack (4-F) endovascular system for repair of postangioplasty dissections in the mid/distal popliteal, tibial, and/or peroneal below-the-knee (BTK) arteries ranging in diameter from 1.5 to 4.5 mm.
News | 04.07.20
One-Year Outcomes Reported for PQ Bypass' Detour System to Treat Femoropopliteal Lesions
April 7, 2020—The 1-year safety and effectiveness results from the DETOUR I trial of the Detour system (PQ Bypass, Inc.) for percutaneous femoropopliteal bypass were published by Dainis K. Krievins, MD, et al online in Journal of Vascular Surgery (JVS). The Detour system percutaneously deploys modular stent grafts to bypass femoropopliteal lesions through a transvenous route.
News | 03.27.20
SIR Issues Clinical Notification on Aerosol-Generating Procedures
March 27, 2020—The Society of Interventional Radiology (SIR) has issued a clinical notification to provide medical decision-making guidance on how to perform aerosol-generating procedures (AGP) safely in the interventional radiology suite.
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.