Drug-coated balloons find niche where DES dare not go

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Drug-coated balloon technology is being adopted in niche applications throughout Europe, and according to Millennium Research Group, the market will continue to grow as physicians increasingly use the technology in cases where other devices may not be suitable.

Although drug-coated balloons “lack extensive clinical data” comparing their efficacy against other technologies, such as drug-eluting stents (DES), they are being employed in patients where drug-eluting stents cannot be used, the report found. For example, patients who are not candidates for dual-antiplatelet therapy are prevented from receiving a DES; in these patients a drug-coated balloon may be a viable treatment option.

MRG also found there is potential to use drug-coated balloons in combination with bare-metal stents to lower the risk of late stent thrombosis, which some believe is caused by the polymers holding the drug onto the stent platform.

Drug-coated balloons also are being used to treat side branches of bifurcated lesions in the coronary arteries and for the treatment of in-stent restenosis. “Although the practice of treating in-stent restenosis with another stent is currently being examined in clinical trials, physicians generally prefer not to perform this type of procedure,” the report authors wrote.

"Although drug-coated balloons have been available in Europe as of 2007, they have experienced only minimal adoption so far," said Adrienne Ma, MSc, an analyst at MRG. "According to physicians interviewed by MRG, it is unlikely that interventional cardiologists will choose angioplasty alone when a stent could be placed. This market will continue to grow as the technology is used to treat patients in which other devices are not well suited. Physicians in Europe will continue to monitor data from clinical trials such as Eurocor's Valentines trial, Lutonix' PERVIDEO I trial, and B. Braun's PEPCAD trials, and positive results will further drive adoption."