Philips Announces FDA 510(k) Clearance and Launch of QuickClear Mechanical Thrombectomy System
September 24, 2020—Royal Philips announced the FDA 510(k) clearance and launch of their QuickClear mechanical thrombectomy system, a compact, single-use system that provides physicians an all-in-one aspiration pump and catheter for the removal of blood clots from the vessels of the peripheral arterial and venous systems.
AOTI’s Topical Wound Oxygen Product Line Expanded for Treating Larger Limbs
September 16, 2020—Advanced Oxygen Therapy, Inc. (AOTI) announced an expansion of its multimodality Topical Wound Oxygen (TWO2) therapy product family with the addition of a new larger-extremity chamber for the treatment of nonhealing chronic wounds in patients with peripheral vascular disease.
Clinical Practice Guidelines on IVC Filter Use Published
September 9, 2020—The Society of Interventional Radiology announced that new clinical practice guidelines developed by a multidisciplinary panel on the use of inferior vena cava (IVC) filters in patients with venous thromboembolism (VTE) were published by John A. Kaufman, MD, et al online in Journal of Vascular & Interventional Radiology.
HOME-PE Trial Clarifies Which Acute PE Patients Can Be Managed at Home
August 31, 2020—Patients with acute pulmonary embolism (PE) can be selected for home management using either the criteria recommended by European guidelines or those recommended by American guidelines, according to results of the HOME-PE trial, announced by the European Society of Cardiology (ESC).
Mount Sinai Study Demonstrates Efficacy of Anticoagulants for COVID-19 Patients
August 26, 2020—The Mount Sinai Hospital and Icahn School of Medicine at Mount Sinai in New York, New York, announced the publication of findings from an observational study that showed that all regimens of anticoagulants were far superior to no anticoagulants in COVID-19 patients.
Study Compares Treatments to Improve Healing of Chronic Venous Leg Ulcers
August 20, 2020—The Society for Vascular Surgery (SVS) announced that a multicenter, retrospective, cohort study involving > 800 patients with chronic venous leg ulcers (VLUs) demonstrated the relative impact of various treatment modalities as well as their cumulative effect on healing.
First Patient Enrolled in the RESCUE Trial of Thrombolex’s Bashir Catheter to Treat Acute Submassive PE
August 6, 2020—Thrombolex Inc. announced that it has enrolled the first patient in its pivotal RESCUE trial for the treatment of patients with acute submassive pulmonary embolism (PE) using the Bashir endovascular catheter under an investigational device exemption (IDE) from the FDA.
National Blood Clot Alliance Receives CDC Grant to Support COVID-19 Research and Public Awareness Campaign
July 28, 2020—The National Blood Clot Alliance (NBCA), in partnership with the University of Oklahoma, has received an award through an Association of University Centers on Disabilities—Centers for Disease Control cooperative agreement to facilitate and advance research into blood clots as a complication of COVID-19.
Results Published From SAVE-US IDE Study of Bluegrass Vascular’s Surfacer System
July 16, 2020—Bluegrass Vascular Technologies announced that the results of its prospective, multicenter SAVE-US study were published online by Principal Investigator Mahmood Razavi, MD, et al in The Journal of Vascular Access.
Data Presented From Global and European Analyses of Daiichi Sankyo’s ETNA-VTE Study of Edoxaban
July 15, 2020—Daiichi Sankyo Europe GmbH announced results from five analyses of 12-month data from ETNA-VTE, a noninterventional safety study evaluating edoxaban (Lixiana, Daiichi Sankyo) treatment in routine clinical practice in patients with venous thromboembolism (VTE).
Study Evaluates Rivaroxaban Versus Warfarin in Obese Patients With Acute VTE
July 13, 2020—An analysis of electronic health record (EHR) data was conducted to evaluate the effectiveness and safety of rivaroxaban (Xarelto; Bayer AG and its partner Janssen Research & Development, LLC) versus warfarin for treatment and prevention of recurrent venous thromboembolism (VTE) in obese patients.
Medtronic's ABRE Venous Stent Study Meets Safety and Effectiveness Endpoints; 12-Month Data Presented
June 16, 2020—Twelve-month data from Medtronic's ABRE pivotal, investigational device exemption, venous stent study were presented by Stephen Black, MD, during a Charing Cross (CX) 2020 virtual session dedicated to deep venous disease.
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.
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.
Sponsored by Penumbra, Inc.
Rethinking Thrombus Removal With the Indigo System: Introducing Lightning Intelligent Aspiration
With Frank R. Arko III, MD; Patrick E. Muck, MD, RVT, FACS; Ripal T. Gandhi, MD, FSIR, FSVM; Robert Lookstein, MD, MHCDL, FSIR, FAHA, FSVM; Michael S. Rosenberg, MD, FSIR, FACR; Eric Moldestad, MD; Gianmarco de Donato, MD; Thomas S. Maldonado, MD; and D. Chris Metzger, MD
Sponsored by Inari Medical
Reversing the Death Spiral: FlowTriever Thrombectomy for High-Risk PE
A panel of experts shares their high-risk PE treatment strategies and an update on the FLAME study, plus case reports of FlowTriever thrombectomy use in high-risk patients after cardiac arrest.
With James Horowitz, MD, FACC; Mitchell J. Silver, DO, FACC, FSVM, RPVI; Catalin Toma, MD; Pavan Khanna, MD; Mitchell Weinberg, MD; and Andrew Galmer, DO
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.