Consensus Statement Published on the Use of Intravenous Iodinated Contrast Media in Patients With Kidney Disease
January 22, 2020—A consensus statement from the American College of Radiology and the National Kidney Foundation addresses the use of intravenous iodinated contrast media in patients with kidney disease.
FDA Grants Breakthrough Device Designation for MedAlliance’s Selution SLR Device for AVF Indications
January 14, 2020—MedAlliance announced that it has received FDA Breakthrough Device designation for the company's Selution SLR sirolimus-eluting balloon catheter for arteriovenous fistula indications.
Two-Year Data Reported for Avenu’s Ellipsys Vascular Access System
December 5, 2019—Access Solutions, a provider of patient advocacy consulting services in the dialysis industry, announced the publication of a study reporting high levels of patient satisfaction with a minimally invasive endovascular approach to creating vascular access for patients who require hemodialysis.
Medtronic's In.Pact AV DCB Approved by FDA to Treat Arteriovenous Fistula Lesions
November 21, 2019—Medtronic announced FDA approval of the In.Pact AV drug-coated balloon (DCB), a paclitaxel-coated balloon indicated for the treatment of failing arteriovenous (AV) access in patients with end-stage renal disease (ESRD) undergoing dialysis.
Findings Presented From a Subgroup Analysis of Medtronic's In.Pact AV DCB
November 6, 2019—Medtronic announced that findings from a 6-month subgroup analysis from the IN.PACT AV Access trial were presented by Robert Lookstein, MD, in a late-breaking clinical trial session at VIVA 2019, the Vascular InterVentional Advances meeting held November 4–7 in Las Vegas, Nevada.
ICU Medical to Acquire Pursuit Vascular
November 4, 2019—ICU Medical, Inc. announced that it has entered into a definitive agreement to acquire Pursuit Vascular, Inc., a privately held medical device company with a primary focus on catheter disinfecting products and technologies to reduce bloodstream infections.
Clinical Results Published for Bluegrass Vascular's Surfacer System
September 24, 2019—Bluegrass Vascular Technologies announced that results associated with the clinical use of the company’s Surfacer Inside-Out access catheter system were published by Dirk M. Hentschel, MD, et al in The Journal of Vascular Access (JVA).
Medtronic's IN.PACT AV Access Trial Meets Primary Safety and Efficacy Endpoints
September 7, 2019—Medtronic announced that the first results from the IN.PACT AV Access clinical study were presented at CIRSE 2019, the annual conference of the Cardiovascular and Interventional Radiology Society of Europe held September 7–11 in Barcelona, Spain.
FDA Grants Breakthrough Device Designation for Concept Medical's MagicTouch AVF Sirolimus-Coated Balloon
August 29, 2019—Concept Medical Inc. announced that it has been granted FDA Breakthrough Device designation for the company's MagicTouch arteriovenous fistula (AVF) sirolimus-coated balloon (SCB) catheter for the treatment of stenotic lesions of AVFs or AV grafts (AVGs) in hemodialysis treatment of renal failure.
Continuing Coverage: Paclitaxel In PAD
Meta-Analysis Evaluates Mortality After Paclitaxel-Coated Device Use in Dialysis Access
August 28, 2019—Krystal Dinh, BMed, et al, published findings from an investigation of the risk of all-cause mortality in patients who underwent dialysis access treatment using paclitaxel-coated devices compared with percutaneous transluminal angioplasty (PTA) with an uncoated balloon.
Study Supports Laminate's VasQ External Support Device for Newly Created Arteriovenous Fistulas in Hemodialysis Patients
August 23, 2019—Laminate Medical Technologies announced that the first multicenter, randomized controlled study of the company's VasQ external support device for newly created arteriovenous fistulas (AVFs) in hemodialysis patients was published online ahead of print by Nikolaos Karydis, MD, et al in American Journal of Kidney Diseases.
Enrollment Completed in the United States Pivotal Trial of Bluegrass Vascular's Surfacer System
June 4, 2019—Bluegrass Vascular Technologies, Inc. announced that it has completed enrollment of the SAVE-US pivotal trial evaluating the safety and efficacy of the company's Surfacer Inside-Out access catheter system in 30 patients at seven centers in the United States.
Global Roundtable: Real-World Experience With Drug-Coated Balloons in AV Access
Experts discuss the current use of DCBs in AV fistulas and review how upcoming trials may influence progress in this space.
With Andrew Holden, MBChB, FRANZCR, EBIR; Farah Gillan Irani, MBBS, FRCR, FAMS; Dimitrios Karnabatidis, MD, PhD, FCIRSE; Panagiotis M. Kitrou, MD, MSc, PhD, EBIR; Bien Soo Tan, MBBS, FRCR, FAMS; and Scott O. Trerotola, MD
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.