Join us at BSIR 2023 for our symposium:
One proven drug-coated balloon — treating two vessel beds
Wednesday 8 November, 2023
12:45 - 13:15 | Auditorium 2
Dr. Rob Morgan FRCR EBIR-ES
Consultant Interventional and Diagnostic Radiologist
St George's University Hospitals NHS Foundation Trust
Dr. Kate Steiner MRCP FRCR
Consultant Interventional Radiologist
Lister Hospital, East and North Hertfordshire NHS Trust
By attending, you will:
Review the clinical data for IN.PACT™ Admiral™ across two vessel beds
Explore the IN.PACT™ Admiral™ long-term efficacy and safety results
Hear case reviews and real-world experiences using IN.PACT™ Admiral™
Learn more about the recent patient level meta-analysis on paclitaxel safety, conducted and recently presented in the US
Listen to the opinions of experts and learn about the position from CIRSE, regarding the use of paclitaxel coated devices in the treatment of peripheral artery disease
The most comprehensive analysis of clinical data to date affirming the safety of paclitaxel-coated devices to treat peripheral arterial disease, was published in The Lancet and presented at the TCT conference on Oct. 24, 2023.
The data confirms there is no excess mortality risk associated with paclitaxel-coated devices and just as importantly, no relationship between dose and mortality was identified either.
This patient-level, pooled analysis of pivotal randomized controlled trials, conducted with input from the FDA, provides the most complete and current follow-up data of pivotal studies associated with FDA-approved paclitaxel-coated devices.
With five-year vital status available in 95% of evaluable patients and a comprehensive examination of the impact of treatment-group crossovers, this initiative represents the most complete patient-level analysis to date, or likely to be available in the future.
No association between mortality risk and paclitaxel-coated device exposure or dose was observed in any of the pre-specified analytic approaches.
500,000+ patients treated worldwide
No device or procedure-related deaths through 5 years4
75% of patients treated with IN.PACT™ Admiral™ DCB+ remain reintervention-free through 5 years4
3 year sustained results for AV fistula lesions versus PTA1,2,3
†The approved product name for the drug-coated balloon is IN.PACT™ Admiral™ Paclitaxel-coated PTA Balloon Catheter
See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.uk-en.
Lookstein RA, et al. Drug-Coated Balloons for Dysfunctional Dialysis Arteriovenous Fistulas. N Engl J
Med2020;383:733-42. DOI: 10.1056/NEJMoa1914617. Highlighted results reported at both 180 and 210 days.
Trerotola SO, Saad TF, Roy-Chaudhury P; Lutonix AV Clinical Trial Investigators. The Lutonix AV Randomized Trial of Paclitaxel-Coated Balloons in Arteriovenous Fistula Stenosis: 2-Year Results and SubgroupAnalysis. J Vasc Interv Radiol. January 2020;31(1):1-14.e5.
Holden A. The IN.PACT AV Access Study: Results through 36 Months. Presented at Charing Cross 2022.
IN.PACT Admiral 5Y data: Laird JA, Schneider PA, Jaff MR, et al. Long-Term Clinical Effectiveness of a Drug-Coated Balloon for the Treatment of Femoropopliteal Lesions. Circ Cardiovasc Interv. June 2019;12(6):e007702, presented by Thomas Zeller, M.D., at VIVA 2020.
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