PACLITAXEL SAFETY

IN.PACT Admiral Drug-Coated Balloon

Dedicated to transparency 

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.


Paclitaxel Safety in the Periphery:
A Review of Current Literature and Guidelines

This CME-accredited discussion covers the main topics and questions that the physician community has been asking:

  • Informed patient consent regarding paclitaxel safety
  • Patients at high risk of restenosis and the IN.PACT Admiral DCB data for these patients
  • Implications of big data (CMS, Medicare) and how to interpret these data sets
  • Analysis of the FDA letter from August 2019, and implications for daily practice
Group of physicians having panel discussion
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FACULTY

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

Dr. Dan Clair: An update on the FDA-Panel and the impact on practice

 Panel Discussion

Does Drug Dose Impact Mortality Following PAD Treatment with Paclitaxel-eluting or Coated Devices? - (36:22)

A Panel Discussion: Andrew Holden, M.D.; Michael R. Jaff, D.O.; Peter A. Schneider, M.D.
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IN.PACT PATIENT-LEVEL META-ANALYSIS

DCBs Over The Long-Term: Are They Safe For Our PAD Patients? - (13:52)

Insights from the IN.PACT DCB Program: Peter A. Schneider, M.D.
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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  

  

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There was NO difference in total mean dose of paclitaxel between DCB patients who survived vs. those who died.1

View Nominal Dose Data
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There was no correlation between survival status of patients stratified by paclitaxel dose.1

View Dose Tercile Data
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Paclitaxel was not identified as a predictor for mortality in a multivariable analysis.1 

View Multivariable Analysis

RESOURCES 

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

1

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.