Bring That Pioneering Spirit Back! A 25-Year Perspective on the Vascular Stent

Abstract

My personal perspective about intravascular stents has been for the most part very positive. From its humble beginnings in the late ‘70s the stent become a major therapeutic resource and has achieved worldwide application. However, some disappointments in the last few years dampened my early unbridled enthusiasm. In my view, during its third decade of life the stent evolution has been hampered by unfulfilled goals. I think this is related to a recent change in attitudes and perceptions by government, industry, the media, and people in general. In regard to technological development, starting in the year 2000 the medical device industry has shown a pervasive reluctance to invest in new research and development. This has been a gradual change from the previous 15 years, when this industry invested boldly in new products, guided only by their instinct and everybody’s expectation that there should be a change in the status quo. Reviewing the circumstances of those days compared to the present, it is apparent that the differences where global and not just limited to biotechnology. The innovative spirit of the ‘80s was evident in the wondrous technological achievements that arose during this decade. The launching of the first space shuttle and the deployment of the first permanently manned space station left us in awe, although they did not affect us personally. Conversely, the advent of practical personal computers, compact discs, and cell phones did. The beginnings of the Internet were laid out by a burgeoning ARPANET and the introduction of the transmission control protocol-Internet protocol (TCP-IP) lead to the World Wide Web. In medicine and biology the development of PCR (polymerase chain reaction) made possible a great expansion in DNA and gene research. Closer to our specialty, it was during the ‘80s that all major innovations in endovascular treatments developed. Andreas Gruntzig, who had done the first coronary balloon angioplasties in Zurich in 1977, moved to Atlanta, Georgia, and started a program of clinical research and teaching with unprecedented success. Under his leadership and inspiration the balloon angioplasty catheter got rapidly refined and the new technique achieved massive acceptance. During those years laser, rotational, and, later, directional atherectomy and the rapid exchange balloon catheter appeared, and so did stents. Unquestionably, a new revolution in vascular therapy had started then, with lots of new technologies and applications of these technologies in very innovative ways. President Ronald Reagan, who reflected on innovation in his State of the Union Address before the U.S. Congress in February 1985 [1], said: “Let us begin by challenging our conventional wisdom. There are no constraints on the human mind, no walls around the human spirit, no barriers to our progress except those we ourselves erect.” More interestingly, his comments on vascular therapy were quite foretelling of ongoing developments: “New laser techniques could revolutionize heart bypass surgery … and hold out new promise for saving human lives.” The specialized medical press was quick to bring attention to the new trends and to prepare the public for the changes that occurred a few years later. The social impact was huge, as millions of patients got access to the new percutaneous techniques and, inevitably, open surgical treatments diminished. Endovascular equipment got increasingly refined and doctors’ skills steadily improved. The new endovascular treatments changed from being the exclusive domain of primary referral centers to being available at smaller, peripheral hospitals. The competition between device manufacturers became fierce for an increasingly lucrative stent market opportunity.