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Publications
Publications
  • January 2020
  • Article
  • Journal of Invasive Cardiology

The Market Reacts Quickly: Changes in Paclitaxel Vascular Device Purchasing Within the Ascension Healthcare System

By: Peter P. Monteleone, Subhash Banerjee, Priya Kothapalli, Ariel Dora Stern, Daniel Fehder, Ron Ginor, Dominic Vollmar, Edward T. A. Fry and Mark J. Pirwitz
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Abstract

Background. A meta-analysis of trials in endovascular therapy suggested an increased mortality associated with treatment exposure to paclitaxel. Multiple publications and corrections of prior data were performed, and the United States Food and Drug Administration has issued multiple advisories regarding paclitaxel use. We analyzed how this controversy impacted device purchasing and related utilization patterns in the period immediately following publication of the meta-analysis.
Methods and Results. Ascension Healthcare System purchase data over a 14-month period were synthesized across centers for both paclitaxel and non-paclitaxel devices. A fixed-effects regression model and a binary regression model with facility-level controls were used to compare purchasing patterns before and after the meta-analysis. Purchase volumes of each paclitaxel device fell. Pooled purchase volumes of all paclitaxel devices decreased from a 14-month peak of 631 devices in October 2018 to a 14-month nadir of 359 devices in February 2019. An F-test comparing the pooled-month specific fixed effects for the months before vs. after the publication of the meta-analysis has an F-statistic of 11.64, suggesting that average purchasing levels in the two periods are statistically different (P<.001). Utilization of non-paclitaxel devices did not decline.
Conclusions. Purchase volumes of paclitaxel devices decreased immediately during the months following publication of the related meta-analysis. Total Ascension-wide paclitaxel device purchase volume in February 2019 demonstrated a 43.1% reduction from peak monthly purchase volume during the assessed period and a 32.5% reduction compared with November 2019, the last month preceding publication of the meta-analysis.

Keywords

Medical Devices; Health Testing and Trials; Analysis; Sales

Citation

Monteleone, Peter P., Subhash Banerjee, Priya Kothapalli, Ariel Dora Stern, Daniel Fehder, Ron Ginor, Dominic Vollmar, Edward T. A. Fry, and Mark J. Pirwitz. "The Market Reacts Quickly: Changes in Paclitaxel Vascular Device Purchasing Within the Ascension Healthcare System." Journal of Invasive Cardiology 32, no. 1 (January 2020).
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About The Author

Ariel D. Stern

Technology and Operations Management
→More Publications

More from the Authors

    • February 2023
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    The Brigham and Women’s Hospital Innovation Hub: Driving Internal Innovation

    By: Ariel Dora Stern, Robert S. Huckman and Sarah Mehta
    • 2023
    • JAMA, the Journal of the American Medical Association

    Association Between Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance

    By: Alexander O. Everhart, Soumya Sen, Ariel D. Stern, Yi Zhu and Pinar Karaca-Mandic
    • 2022
    • Faculty Research

    Post-market Surveillance of Software Medical Devices: Evidence from Regulatory Data

    By: Alexander O. Everhart and Ariel D. Stern
More from the Authors
  • The Brigham and Women’s Hospital Innovation Hub: Driving Internal Innovation By: Ariel Dora Stern, Robert S. Huckman and Sarah Mehta
  • Association Between Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance By: Alexander O. Everhart, Soumya Sen, Ariel D. Stern, Yi Zhu and Pinar Karaca-Mandic
  • Post-market Surveillance of Software Medical Devices: Evidence from Regulatory Data By: Alexander O. Everhart and Ariel D. Stern
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