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.

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.

Invatec has grown to be the leading native European interventional vascular device company and has now set its sights on the US market. By focusing first on peripherals and following with drug-eluting balloons, not stents, Invatec is looking to compete against the major device companies on their home turf.