Drug-Coated Balloons Fuel Multibillion-Dollar Hopes

Article preview from Medtech Insight - January, 2013

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.

 

Drug-Coated Balloons Fuel Multibillion-Dollar Hopes

Article preview from Medtech Insight - January, 2013

Interventional cardiology is a medical specialty well known for embracing promising new device technologies, and as a result, the field has progressed over the years well beyond its initial focus on coronary balloon angioplasty and stenting. The specialty’s unique mix of open-mindedness and evidence-based clinical rigor has enabled it to serve as a breeding ground for a number of novel and very lucrative device markets, beginning a decade ago with drug-eluting stents (DES) and continuing today with the two latest pivotal advances in the field: transcatheter aortic valve implantation (TAVI) and transcatheter renal denervation for the treatment of resistant hypertension – both of which appear to be truly disruptive technologies with blockbuster market potential.

This movement by interventionalists to embrace promising transcatheter markets outside of coronary angioplasty and stenting is understandable, given the ongoing pressures on the percutaneous coronary intervention (PCI) space that have driven down US PCI procedure volumes (and provider revenues), along with stent average sales prices, over the past several years.

Ironically, the drop in PCI procedures in recent years can be attributed in part to the success of groundbreaking interventional treatments like DES, which have been responsible for a dramatic reduction in restenosis and repeat procedures, along with effective new disease prevention strategies (such as the widespread use of statin drugs) that appear to be reducing overall US heart disease prevalence. (See Exhibit1.) But there are other, more concerning factors at work in this market as well. Over the past couple of years, the interventional cardiology field has been plagued by several widely published reports of fraud and abuse involving a few US interventionalists who reportedly stented patients unnecessarily, and this has led US providers and payors to institute tighter controls on stent use. Moreover, there is now growing pressure from payors to treat non-emergent coronary artery disease cases with drug therapy rather than PCI – a consequence of the COURAGE trial and similar recent studies showing that stable patients who are treated with optimal medical therapy do just as well as (or, in some cases, better than) those treated with PCI or bypass surgery.

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