Meeting the Demand

M. Lowell Edwards Public History Project

Meeting the Demand

University of Oregon Medical School press release on the Starr-Edwards heart valve

University of Oregon Medical School press release on the Starr-Edwards heart valve

By 1961, Edwards concluded that clinical success with the mitral valve obligated him to establish a business that would produce high-quality cardiac valve prostheses. Edwards founded and incorporated Edwards Laboratory, convincing an old trusted friend, Ray Astle, to join him as the general manager. They rented space in a small building in Santa Ana, California, and with two employees began to manufacture Starr-Edwards mitral valve prostheses one at a time.

Demand for the valves rapidly increased in 1962 and 1963. Edwards and colleagues confronted major problems when trying to achieve reliable production. These were overcome through persistence and unswerving commitment to produce the highest quality valves.

In 1961, after their success with the mitral valve prosthesis, Edwards and Starr turned their attention to inventing a ball-in-cage prosthesis to replace the aortic valve. The function and anatomy of the aortic valve are substantially different from the mitral valve, and thus modifications to the original design were required. The four struts were replaced by three struts of reduced thickness, made of an exceptionally hard alloy, Stellite 21. The sewing ring had to be shaped to conform tightly to the high-pressure flows across the aortic valve. Edwards refined the structure of the aortic valve in incremental steps, attempting to achieve maximum performance. In 1963, Starr and Edwards reported their clinical experience with aortic valve replacement with what they termed their “semi-rigid ball-valve prosthesis.”

Aortic Replacement: Clinical Experience with a Semirigid Ball-Valve Prosthesis. Starr A, Edwards ML, McCord CW, Griswold HE. Circulation. 1963; 27: 779-783.