Drug-Eluting Balloons: Coming of Age in the Periphery
The jury is still on the ultimate utility of stenting and atherectomy in the distal periphery; meanwhile, all eyes are now on an extremely promising new technology that could be a game-changer for this arena: drug-eluting balloons. DEBs are basically angioplasty balloons coated with an antirestenosis drug that is delivered directly to the vessel wall at the time of balloon inflation. They offer numerous advantages over drug-eluting stents in the superficial femoral artery and distal vessels since they leave no implant behind in the vessel that can fracture or cause hypersensitivity reactions and they eliminate the worries of in-stent restenosis and late-stent thrombosis.They may also provide more uniform distribution of the antiproliferative drug in the vessel wall than stents.
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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 were once thought to be an unnecessary innovation because of drug-eluting stents. With DES no longer seen as the panacea for vascular disease, balloons could re-emerge as the next major technology platform, and Lutonix is leading the race to bring them to the US market.
In the interventional cardiology community, 2010 could certainly be considered a breakthrough year for percutaneous heart valve devices. At two major US cardiology conferences: the American College of Cardiology in the spring, and most recently, the Transcatheter Cardiovascular Therapeutics symposium, held in September, impressive results from randomized trials of transcatheter heart valve replacement/repair devices set the venues abuzz and had physicians speculating about possible near-term paradigm shifts in the way heart valve disease will be treated. The big questions now are how long it will take before these devices reach the US market, and exactly how many US patients are likely to be implanted once they are available.