Vulnerable plaque caught investors' and entrepreneurs' attention several years ago as the mysterious cause of more than half of all cases of sudden cardiac death, most of which occurs in people with no history of heart disease. Several companies were launched and much money invested with little to show for it. One major problem: vulnerable plaque requires new tools both to diagnose and treat the condition, which proved to be bigger hurdles than most start-ups can overcome. Prescient was launched by an experienced device management team and is applying Raman spectroscopy, to coronary disease as the basis of its diagnostic tool, and is using a shield-not a stent-for its therapeutic device.

As interest in vulnerable plaque heats up, medical device companies hope to capitalize on their earl y lead. But as vulnerable plaque shifts therapies from structural to biological, that lead many not last long. The second of a two-part series.

Vulnerable plaque is the hottest cardiovascular device opportunity in years. But in shifting thinking about coronary disease from structural to biological processes, it challenges what it means to be a device company. As more evidence suggests vulnerable plaque is a systemic rather than local problem and as the underlying assumptions about coronary disease shift from a structural view to a biological one, conventional device approaches are challenged.

Recent research points to unstable, rather than stenotic plaque, as a major cause of heart attacks. Cardiologists, as much as entrepreneurs and large companies, are therefore driving the creation of new cardiac detection platforms based on characterizing arterial plaque in order to identify patients that are unaware that they are at risk of suffering a myocardial infarction. First-generation detection tools are well along in development, but the scientific understanding about plaque is evolving so rapidly, technologies may be obsolete by the time they are ready for commercialization. Finally, looking for heart attack risk in symptomless patients means screening apparently healthy patients based on risk factors. Clinicians aren't yet prepared for the treatment implications and payers aren't ready for the economic burden of widespread screening, and this presents one of the greatest challenges for companies introducing new plaque detection technologies.