Lutonix: Back To The Future With Drug-Coated Balloons

Article preview from IN VIVO - September 1, 2011

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.

Lutonix: Back To The Future With Drug-Coated Balloons

Article preview from IN VIVO - September 1, 2011

During the peak of the drug-eluting stent (DES) wave in the early to mid 2000s, cardiovascular conferences actually entertained discussions as to whether the era of significant innovation in interventional technology for treating vascular disease had been brought to an end by DES, leaving only small niche opportunities remaining. Since then, the risks of late-stent thrombosis, concerns about the cost and overuse of drug-eluting stents, as well as evidence of clinical areas such as peripheral vascular disease where DES have been ineffective, have shown that it was premature to think drug-eluting stents would prove to be the panacea for vascular disease that some thought they would.

Indeed, some industry executives and clinicians believe that we are about to see the emergence of the next major platform technology to treat vascular disease, following angioplasty balloons, bare-metal stents, and then drug-eluting stents. That is drug-eluting, or as Lutonix Inc. prefers to describe it, drug-coated balloons (DCBs).

The notion of applying drug to an angioplasty balloon to treat vascular disease may sound like a Back To The Future kind of idea, and in fact, the concept is not new. It was tried unsuccessfully back in the early 1990s for coronary disease. The development of drug-eluting stents at first appeared to obviate the need for a drug-coated balloon. However, a small but vocal group of physicians have long argued against therapies that require a permanent implant, and the clinical community as a whole recognizes the ideal long-term value of an implant-free approach such as a balloon-based technology.

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