PACLITAXEL SAFETY
IN.PACT Admiral Drug-Coated Balloon
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IN.PACT Admiral Drug-Coated Balloon
There have been concerns surrounding the safety of paclitaxel in therapies to treat peripheral artery disease (PAD). Medtronic is dedicated to data transparency and confident in the safety and effectiveness of our IN.PACT™ Admiral™ drug-coated balloon.
This CME-accredited discussion covers the main topics and questions that the physician community has been asking:
Peter Schneider, M.D. (Moderator)
Professor of Surgery
Division of Vascular & Endovascular Surgery
University of California San Francisco
San Francisco, California
Daniel Clair, M.D.
Chair, Department of Surgery
Palmetto Health/University of South Carolina Medical Group
Columbia, South Carolina
John Laird, M.D.
Cardiologist
Adventist Heart & Vascular Institute
St. Helena Hospital
St. Helena, California
Sahil Parikh, M.D.
Director of Endovascular Services
Columbia University Medical Center
Assistant Professor of Medicine
Columbia University College of Physicians and Surgeons
New York, New York
Paclitaxel post-FDA
Does Drug Dose Impact Mortality Following PAD Treatment with Paclitaxel-eluting or Coated Devices?
A Panel Discussion: Andrew Holden, M.D.; Michael R. Jaff, D.O.; Peter A. Schneider, M.D.
More information (see more)
Less information (see less)
DCBs Over The Long-Term: Are They Safe For Our PAD Patients?
Insights from the IN.PACT DCB Program: Peter A. Schneider, M.D.
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Less information (see less)
To confirm the safety of our IN.PACT Admiral DCB, an independent, patient-level analysis was conducted by the Baim Institute for Clinical Research, formerly HCRI, on all subjects from all of our studies treated with IN.PACT Admiral DCB. This analysis included 1,980 patients who were enrolled across our IN.PACT clinical programs.
The results from the independent, patient-level analysis found NO correlation between paclitaxel dose and mortality.1
There was NO difference in total mean dose of paclitaxel between DCB patients who survived vs. those who died.1
There was no correlation between survival status of patients stratified by paclitaxel dose.1
Paclitaxel was not identified as a predictor for mortality in a multivariable analysis.1
Medtronic Letter in Response to FDA Paclitaxel Letter
IN.PACT Admiral Patient-level Safety Data
Presented at Charing Cross by Dr. Schneider.
JACC Manuscript
Mortality Not Correlated With Paclitaxel Exposure
An Independent Patient-Level Meta-Analysis of a Drug-Coated Balloon
Peter A. Schneider, John R. Laird, Gheorghe Doros, Qi Gao, Gary Ansel, Marianne Brodmann, Antonio Micari, Mehdi H. Shishehbor, Gunnar Tepe and Thomas Zeller
Schneider P. DCBs Over The Long-term: Are They Safe For Our PAD Patients? Insights From The IN.PACT DCB Program. Presented at Charing Cross 2019; San Francisco, CA.