Behind the DES Debate: A New Model for Device Development?
Executive Summary
The drug-eluting stent is the rare cardiovascular device that has seen large companies dominate not just sales and distribution channels, but product development as well. But this big company dominance/small company exclusion in DES seems to be reversing itself, at least in part, if vibes from this year's PCR are to be trusted. Over the past half year or so, a series of newly released and much debated clinical studies, including BASKET-LATE and the Swedish DES registry SCAAR, have focused attention on DES safety issues, highlighting a small but meaningful risk of late-stent thrombosis, while the COURAGE trial has even pointed to efficacy concerns of percutaneous interventions, generally speaking. And that's opened the door to dozens of small and mid-sized companies that suddenly find themselves in the enviable position of seeing market and clinical pressures accelerating demand for quick development of their technologies.