The Unstable State of Plaque Detection
This article was originally published in Start Up
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.
You may also be interested in...
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.
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.
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.