The long-awaited results of the ISCHEMIA trial showed that patients with asymptomatic stable coronary disease get no apparent benefit from coronary intervention compared to a more conservative strategy with optimal medical management.

With a total market potential estimated in the multibillion-dollar range, the drug-coated balloon opportunity is attracting a growing list of competitors, including several leading multinational cardiovascular device companies that have entered the space via recent acquisitions. DCBs still need to prove their worth in large, long-term clinical trials, but the ultimate proving point for DCBs could center on cost: if they can offer an effective treatment option that is significantly less expensive than existing devices, DCBs may provide a compelling economic argument.

The prospective medical device tax, the continuing decline of venture investing, pricing challenges, austerity measures in Europe, and other headwinds continued to push against the medtech industry in 2012. But emerging clinical and geographic markets, along with an active M&A market, provided the industry with some momentum.