Every week it seems that we get new information from our friends at the American Medical Association or American College of Cardiology about the pending pay cuts for Medicare providers. If that is not enough, it seems on a monthly basis there are new attacks in the media or through medical journals regarding overutilization of percutaneous coronary intervention (PCI) .

The few of us out there who have been performing PCI now for over 30 years sometimes find it hard not to look at these articles and laugh. Of course, elective angioplasty is all about quality of life and relief of angina. It has nothing to do with reducing mortality or even improving left ventricular function. We have shown that PCI in patients who present with acute coronary syndrome can result in a reduction in mortality. As one of the first to report reduction in mortality in patients with cardiogenic shock, I know that PCI in these patients is the standard of care .

In the 1970s, 1980s, and 1990s, we saw a revolution in interventional cardiology. The revolution was brought on by pioneers in the field who were working in a different regulatory environment. Dr. Edward Diethrich and I came upon the idea of perhaps reducing restenosis by placing polytetrafluoroethylene (PTFE) covered stents in the coronary arteries .

As soon as reports came out, a number of interventional gods, such as Antonio Colombo and Steve Ellis, were asking me when we would have a commercially available device. After our report, it only took 3 or 4 years before several manufacturers had commercially available PTFE covered stents that have been primarily utilized as emergency treatment. Now they are an integral part of every catheterization laboratory that does interventional therapy. In 1993, with the help of engineers at Boston Scientific, our group developed the first hydrophilic coronary wire . It took just a few years before wires of this type became commercially available and are probably used in about 10% of angioplasties performed in the United States. These wires are also frequently used in chronic total occlusion (CTO) procedures, but more on that later.

In the early 1990s, working with a Japanese engineer, we developed the first radiofrequency wire. Within 5 or 6 years, radiofrequency wires became commercially available with a sophisticated imaging system .

As an inventor, it seems over the last 4 or 5 years that things have ground to a halt in the United States. In the past, one could present technology such as these mentioned and within a very short period of time an agreement has occurred and the companies begin making prototypes for you. Now it appears one must spend a substantial amount of money to get through the approval process before sales can occur. We recently successfully did this with a snare device that we developed both for large vessels and for CTOs .

There certainly is a need for innovation in interventional cardiology today. Drug-eluting balloons and resorbable stents are being utilized in various applications; however, from a regulatory standpoint, the question is how long is this going to take for their approval to take place in the United States. We are clearly lagging behind our European colleagues as well as the rest of the world with our regulatory process.

Percutaneous valves are here, but again mainly utilized outside the United States. However, from an innovation standpoint there are opportunities, since the vascular complications are still too high and embolic phenomenon occur frequently, which is why a number of us have been working on various embolic protection and vascular improvements .

Clearly, there are opportunities for improvement in technology, but one thing has to be clear: you need to show that whatever device you develop it must be cost effective. The days of expensive technology for technology sake are over.

In terms of innovation, the so-called final frontier of interventional cardiology is CTO PCI. This population, which is the single reason most patients undergo bypass today, introduces great opportunities for innovation. This is what prompted us to develop new wires and support catheters over the years . This is one of the reasons why we are excited at Cardiovascular Research Technologies (CRT) to put together a CTO group in the United States working with European and Japanese colleagues. We are looking forward to resurrecting the CTO Club at CRT in March of 2012. Stay tuned.

Innovation in CTO I think will continue in the future, and I think it has potential to bare fruit. On the other hand, any new device needs to be cost effective and make the procedure easier, safer, and/or quicker.

When one thinks about innovation, are you born an innovator or can it be developed? The Biodesign Group at Stanford has put together a program for fellows, both engineers and physicians, to learn the process. The process is not as simple as one thinks. Sometimes the nonscientist, but the great observer, can make a contribution that is not seen by the interventionist for he/she cannot see the forest through the trees. We think that programs such as the one at Stanford are one way to teach people to be innovators. We are so excited about this that we are starting a similar program, Phoenix Medical Device Innovation Fellowship, which we hope to start next year. Through groups like the groups at Stanford, as well as through our program, we think innovation can occur in the 21st century not only in interventional cardiology, but also in other aspects of medicine. However, this is a different regulatory environment than in the past. Patient safety is paramount and it is also going to take more time and more expense and more know-how to be able to move even a blockbuster medical device forward.