This book covers two areas, the first detailing the concepts and technologies of drug-device combination products. The second area includes case studies of important products that either significantly shape our technologies and thinking, or contribute to current healthcare practice.

The book:Discusses where drugs and devices work, where they fail, and when they need to work with each otherReviews interactions between human bodies and the drug-device combination products the measurements of these interactionsCovers  how a drug-device combination product is developed, tested, and regulatedIncludes case studies of steroid releasing leads, AOA treated tissue heart valves, intrathecal drug delivery pumps, infuse bone grafts, drug eluting stents, and antimicrobial meshes

SuPing Lyu, PhD, joined, is a Principal Scientist at Medtronic, Inc., and his research focuses?on drug-device combination products, biomaterials, and biomaterial-biological interactions. He is a visiting professor of the Minnesota Center for Industrial Mathematics, School of Mathematics at University of Minnesota?and has?been a guest lecturer of biomaterials for the?university since 2006. In addition to authoring over 25 peer-reviewed papers, Dr. Lyu?served as an associate editor for theIEEE/EMBC 2009 conference.

Ronald A. Siegel, ScD, is Professor of Pharmaceutics and Biomedical Engineering at the University of Minnesota.?He is also Program Director of the Biomaterials and Pharmaceutical Materials program of Industrial Partners for Research in Interfacial and Materials Engineering.?Professor Siegel has published over 100 papers primarily on hydrogels, drug delivery devices, microsensors, and mathematical modelling of transport. He has received several research and best paper awards from both CRS and AAPS.

FOREWORD vii

PREFACE ix

PART I BACKGROUNDS 1

1 Addressing Medical Device Challenges with DrugDevice Combinations 3

2 Historical Survey of Drug Delivery Devices 39

3 Development of Combination Product Drug Delivery Systems 66

4 DrugMaterial Interactions, Materials Selection, and Manufacturing Methods 89

PART II PRODUCTS 117

5 Steroid-Releasing Lead 119

6 Thromboresistant Vascular Graft 142

7 Device-Enabled Drug Infusion Therapies 182

8 Promus Element Plus®: A Drug-Eluting Stent 214

9 Infuse® Bone Graft 241

INDEX 261