Volcano's Second Act
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.
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Whatever happened to vulnerable plaque? More than a decade ago, vulnerable plaque was a hot topic that was hoped would explain many incidents of sudden cardiac death in patients without other symptoms of coronary artery disease. While many experts believe the theory underlying this concept remains sound, proving its validity and then developing both diagnostic tools to identify what have been called "vulnerable patients" and then therapeutic devices to treat them has turned out to be a difficult and lengthy challenge that remains unsolved. InfraReDx Inc. remains active in this area, and according to CEO and founder James Muller, MD, is closing in on a solution. InfraReDx recently raised $21 million in its Series D financing round.
In the world of medical devices, there are companies that begin by developing one thing and wind up doing something altogether different. But few have taken the kind of path that Volcano has. Once a high-flying dynamo with dreams of striking it big in vulnerable plaque, Volcano has seen those dreams all but disappear. But instead of crashing to earth Icarus-like, Volcano is soaring, this time on the back of the unlikeliest of technologies, intravascular ultrasound (IVUS), and a business built on a number of opportunistic commercial moves made while still forging ahead in vulnerable plaque. Volcano's new vision: that of a therapy-guidance leader, a "theranostic company," that helps physicians understand whom, how, and when best to treat.
Stent failure is a significant risk in endovascular procedures such as coronary angioplasty. The two primary causes of morbidity and mortality following stent placement are in-stent restenosis (scar tissue growing within the stent and clogging the artery) and in-stent thrombosis (clot formation within the stent, resulting in blockage of arterial blood flow). CorNova strives to treat or eliminate these two common stent complications by integrating innovative technologies into the procedures and devices that practitioners are already using. The company's flagship product, the FiberHalo stent delivery and angioplasty catheter, consists of tiny fiber optics that have been integrated into the catheter itself to measure the vessel from inside the balloon and detect final stent expansion., because stent under-expansion is the leading cause of stent failure.