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Developing Drug-Device Combination Products With Unapproved Components

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Clinical Evaluation of Medical Devices

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Abstract

The development of combination products (CPs) is a challenging field that faces complex product jurisdiction and development issues. Despite these issues, companies are driven by the potential therapeutic success of combining two components into a single product. The driving force behind this new enthusiasm is the local delivery of drugs or biologics to a specific tissue, thereby minimizing the exposure of the whole body to potential toxic compounds as well as maintaining drug/biologic levels at a specific site within a tissue to obtain a desired therapeutic response. As a recent example, Cordis, a subsidiary of Johnson & Johnson, successfully commercialized the CYPHER™ Sirolimus-Eluting Coronary Stent, bringing cardiologists a promising new therapy for the prevention of restenosis. The CYPHER Sirolimus- Eluting Coronary Stent consists of a device that brings a drug component to the coronary tissue to maintain vessel patency by minimizing the occurrence of restenosis following stent implantation. The device component provides mechanical prevention of restenosis, whereas the drug component delivers a pharmacologic/biologic locally to assist in the vessel’s recovery from any injury caused by the stent implantation. Cordis developed this product with both speed and regulatory finesse. The dramatic clinical trial results indicate the CYPHER Sirolimus-Eluting Coronary Stent is a very promising new therapy.1

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Author information

Authors and Affiliations

  1. Drug Development Programs, MDS Pharma Services, Montreal, Quebec, Canada

    Guy Chamberland MSc, PhD (Program Director)

Authors
  1. Guy Chamberland MSc, PhD
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Editor information

Editors and Affiliations

  1. Becker & Associates Consulting Inc., Washington, DC

    Karen M. Becker PhD

  2. Discovery Health Channel, Silver Spring, MD

    John J. Whyte MD, MPH

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© 2006 Humana Press Inc., Totowa, NJ

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Chamberland, G. (2006). Developing Drug-Device Combination Products With Unapproved Components. In: Becker, K.M., Whyte, J.J. (eds) Clinical Evaluation of Medical Devices. Humana Press. https://doi.org/10.1007/978-1-59745-004-1_9

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