Launched in 2000, Volcano was a promising device start-up in what was seen at the time as one of the most exciting opportunities in cardiovascular medicine to come along in some time: vulnerable plaque. But the practical implications of vulnerable plaque have proved to be elusive, for both cardiologists and product companies. For one thing, while everyone agrees that vulnerable plaque is a fascinating concept, no one yet knows precisely what approach will work best, both in diagnosing the disease and treating it. . As the science of vulnerable plaque evolves, that evolution raises questions about the future relevance of a whole generation of tools to serve interventional cardiology. Thus, companies, like Volcano, that placed early bets on technology based on standard interventional cardiology tools, such as catheter- and guide wire-based devices, have had to hold somewhat contradictory thoughts in their mind at the same time: the benefits of conforming to existing approaches and methodologies in interventional cardiology and the likelihood that vulnerable plaque fundamentally changes certain basic assumptions of that specialty.

Italy has become the most favored European point-of-entry for many US device start-ups. NGC Medical, Italy's leading hospital distributor, is responding to hospitals' needs to shift the risk burden to maintain the pace of cardiovascular innovation.

Over the past several years, new tools have helped interventional cardiologists capture patients who historically would have been candidates for surgery. Drug-eluting stents are apt to only increase this trend. These technology innovations have sparked the latest round of proclamations that there is no future in cardiac surgery since the sector's largest component--bypass--is waning, and that the only worthwhile coronary device investment opportunities lie in products with interventional applications. Yet cardiac surgery remains a major device opportunity. A significant increase in M&A activity and recent later-round financings by companies like Percardia and Converge indicate that investing in cardiac surgery start-ups remains alive and well, albeit with new challenges. Indeed, some investors believe that heart surgeons, traditionally conservative adopters of new technology, are now more receptive than ever to new devices and procedures because of the threat to their livelihoods posed by interventionalists' increased encroaching on surgeons' core patients.

Facing unprecedented scrutiny from major media and the US Senate, leading GPOs are beginning to revamp their policies to address concerns on the part of small suppliers that the current system unfairly excludes them. But given the animosity between the two sides, will there ever be a meeting of the minds on GPO reform?