FDA Clears Transit Scientific’s XO Score Angioplasty Scoring and Cutting Platform
June 4, 2020—Transit Scientific announced FDA clearance for the XO Score percutaneous transluminal angioplasty (PTA) scoring sheath platform for use in iliac, iliofemoral, popliteal, infrapopliteal, and renal artery disease plus synthetic and/or native arteriovenous hemodialysis fistula.
Enrollment Begins in the SAVE Global Study of MedAlliance's Selution SLR for AV Fistula
April 14, 2020—MedAlliance announced enrollment of the first patient in the SAVE study evaluating the use of the Selution SLR sirolimus-eluting balloon for dysfunctional arteriovenous (AV) access treatment indications.
ASDIN and VASA Issue Statement on Maintaining Lifelines for ESKD Patients
March 24, 2020—The American Society of Diagnostic and Interventional Nephrology (ASDIN) and the Vascular Access Society of the Americas (VASA) issued a joint statement, "Maintaining Lifelines for End-Stage Kidney Disease (EKSD) Patients" to address challenges of the COVID-19 pandemic.
National Kidney Foundation Urges HHS to Allow Transplant Surgeries and Dialysis Procedures During COVID-19 Outbreak
March 19, 2020—The National Kidney Foundation (NKF) announced in a letter, available online, to Secretary Alex Azar of the Department of Health and Human Services that the NKF is urging the Trump Administration to distinguish which procedures are truly elective and nonessential from procedures that have immediate, significant, and life-long benefits for patients—like organ recovery and kidney transplant as well as dialysis access procedures.
Fist Assist Device Approved and Launched in Europe
February 21, 2020—Fist Assist Devices, LLC, announced CE Mark approval for its wearable Fist Assist intermittent compression device to increase vein diameter before fistula placement and to assist in fistula vein dilation for hemodialysis for end-stage renal disease patients.
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.
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.