Drug-Eluting Balloons: Promise Versus Practicalities

Article preview from Start-Up - June 1, 2011

Drug-eluting balloons might someday pick up where drug-eluting stents leave off, promising to solve problems not addressed - and even created - by DES. However, despite what interventional cardiology companies have learned about device and drug combinations, the drug-coated balloon markets aren't as simple as they might at first seem.

Drug-Eluting Balloons: Promise Versus Practicalities

Article preview from Start-Up - June 1, 2011

Problems drive progress, or so say the adherents of positive thinking. In the short term, problems can be irritating stumbling blocks, but in the long run, their solutions can often offer widespread benefit to an entire industry. This is true of interventional cardiology. Throughout its history, that specialty has seen its share of problems, but the inventiveness of device companies and the appetite for technology among interventional cardiologists have helped solve many of them.

Balloon angioplasty emerged in the late 1970s as a minimally invasive way to unblock clogged arteries. Following the procedure, however, vessels were apt to close abruptly because of dissection or elastic recoil. In as many as 40% of patients, restenosis occurred. Hence, stents were implanted to provide a scaffold that would hold the artery open. After a time, it became clear that in more than a quarter of patients, stented vessels would become blocked once again because of the vessel's response to the injury caused by angioplasty and stenting. To avoid in-stent restenosis, drug-eluting stents entered the marketplace in 2003, coated with the anti-proliferative drug paclitaxel, the immunosuppressant Sirolimus or other drugs of the limus family. Today, drug-eluting, rather than bare-metal, stents are the standard of care for coronary artery disease, at least in the US, (but not necessarily in other parts of the world), accounting for 77% of the one million coronary stenting procedures in the US in 2010, according to Medtech Insight's October 2010 report, "U.S. Markets for Percutaneous Transluminal Coronary Angioplasty and Coronary Stenting Products." But the new solution once again produced new problems.

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