US Cardiovascular Sector In Need Of A Jolt From First-of-A-Kind Balloons And Stents
The US interventional cardiology market will continue to exhibit weak growth in the next five years, but there will be pockets of healthy growth, such as in coronary thrombectomy devices. According to Medtech Insight’s latest report on the sector, growth to 2018 will also be supported by several other factors.
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Manufacturers are finding it harder to innovate in the vascular interventional devices as market and regulatory pressures take their toll. New coronary drug-eluting stents face a difficult challenge with the high bar now set by existing devices, and there have been several recent disappointments in renal denervation, drug-coated balloons, and renal artery stenting; still there are some promising areas, with bioresorbable stents offering perhaps the best prospect among vascular therapies for future blockbuster status.
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.
Officials from the US Food and Drug Administration cited their reasons for refusing to review new applications for companies with unresolved data integrity failures.