Last September 15th and 16th, as a member of the IAGS (International Andreas Gruentzig Society), I felt privileged for the opportunity to participate in an absolutely unique and most inspiring event: a trip to Zürich, Switzerland to celebrate the 30th anniversary of Andreas Gruentzig’s first coronary angioplasty. As if going to the same hospital where it all happened on September 16, 1977 and gathering in the same auditorium where some of the first-ever live demonstration courses took place (Figure 1) were not enough, we were presented with an even greater surprise: the chance to meet Andreas’ very first PTCA patient! It was nothing short of unbelievable, and a most powerful experience. The memories will surely last the rest of our lives. We were also treated with the chance to meet (and listen to) writer David Monagan, who has devoted a large portion of his life to researching and understanding the Gruentzig story and related events. Better yet, this is now available to all with the publication of his new book.¹

With the aforementioned in mind, I thought it would be appropriate to reflect on the impact of Gruentzig’s contribution and on innovation in general — especially the relatively few new therapies and technologies that have done so much to advance — in truth, create — the endovascular specialty. I hope most readers will agree with me on the choice of key developments in our field (Table 1): innovations and innovators that have truly transformed the vascular landscape. The Game-changers. Just how did they manage to do it? A healthy dose of genius and foresight is no doubt required. But also hard work and the difficult-to-define ability to make it all happen: from idea and conception to a palpable emerging new technology that can be developed into a clinically applicable therapy with a marketable product that can be manufactured in a large scale… not an easy or simple task, for sure!

Presently, I would venture to say we have no shortage of ideas and innovators, but the challenges they face are far greater than in the past. The current regulatory environment has injected a huge measure of complexity and risk into the emerging technology field. It has become so difficult and burdensome that many are beginning to wonder whether it may soon “kill” innovation in the United States… or, at a minimum, slow it down far behind developments in other parts of the world. This was, in fact, the focus of a major discussion at the recent International Symposium on Endovascular Therapy (ISET) this past January. It was noted, for instance, that the number of devices and medical therapies reaching the market (“approvals”) has decreased significantly in the current decade when compared with the 1990s — despite an asymmetrical increase in U.S. biomedical research funding (up to nearly $100 billion) between 1994 and 2003.

While “panic” and “despair” would be inappropriate and a bit exaggerated, the current state of affairs is serious enough to warrant paying close attention. And a measure of concern is indeed appropriate as the U.S. may well be losing ground to other countries in the all-important area of emerging technologies and device development. What the likes of Fogarty, Dotter, and Gruentzig, (among others), managed to achieve in the 1960s and 70s and how they did it would be almost inconceivable today. Their efforts would certainly fly in the face of multiple layers of regulation and other constraints. But let’s also recognize that the current regulatory landscape is one that provides for much greater protection to the public. The regulatory agencies’ focus on safety and efficacy is most appropriate and, in truth, a point of reference for almost everyone around the world. This applies most particularly to class III devices.

In the end, resolution of these issues will require the ability to achieve a reasonable balance between the forces of innovative, new technologies and providing protection for the public. Regulation is here to stay, as are economic and legal challenges, but they need not stifle innovation.