Standard Handbook of Biomedical Engineering and Design

Chapter 20: CARDIOVASCULAR DEVICES

Kenneth L. Gage and William R. Wagner

University of Pittsburgh, Pittsburgh, Pennsylvania

20.1 INTRODUCTION

Cardiovascular disease remains the leading cause of mortality among men and women in Western countries. Many biomedical engineers have focused their careers on the study of cardiovascular disease and the development of devices to augment or replace function lost to the disease process. The application of engineering principles to device design has improved device function, while minimizing some of the detrimental side effects. Progress to date has allowed complex, challenging cardiovascular surgical procedures (e.g., open-heart surgery) and medical therapies (e.g., dialysis) to become routine, although limitations remain. In this chapter, eight major categories of cardiovascular devices are addressed, including cardiac valves, stents and stent grafts, pacemakers and implantable defibrillators, vascular grafts, hemodialyzers, indwelling catheters, circulatory support devices, and blood oxygenators. For each topic, the market size, indications for device use, device design, complications and patient management, and future trends are covered. The intent is to provide a brief introduction to the current status of cardiovascular device development and application and to identify challenges that remain in the field.

20.2 ARTIFICIAL HEART VALVES

Market Size

There were at least 60,000 valve replacement operations performed in the United States during 1996 (Vongpatanasin et al., 1996). About two-thirds of the artificial heart valve market in the United States consists of various mechanical valves, with the remaining one-third being distributed among the bioprosthetic, or tissue-based, models. Worldwide, the mechanical valve market is slightly less, approximately 60% of market share...

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