Seven years after the technology’s advent in Europe, the first drug-eluting balloon (DEB) has gained approval in the US. The earlier than expected approval for C. R. Bard’s Lutonix means that the company has pipped Medtronic to the post and has a temporary monopoly in a market that is forecast to be worth $100m just next year.
But Medtronic, the only other realistic player in the US DEB space for some time to come, will arrive soon enough and take a share of that $100m for itself. Its device, IN.PACT Admiral, will not have to undergo an adcom, and is expected to be greenlit by the FDA at the beginning of next year.
DEBs are used to treat blockages in the peripheral arteries, and in contrast to drug-eluting stents do not leave anything behind in the body (Therapeutic focus – Drug-eluting balloons could expand US market, July 8, 2013). They are inserted via a catheter into the narrowed part of the artery and inflated, enabling their drug coating to come into contact with and be absorbed by the endothelium. They are then deflated and removed.
Around eight million patients in the US have peripheral artery disease, first-line treatment for which is angioplasty using a non-drug-coated balloon. It is possible that DEBs could take over as the standard of care, just as drug-eluting stents have largely superseded bare-metal stents.
Lutonix had been expected to hit the US at about the same time as Medtronic’s device, though June’s unanimously positive FDA panel vote for Bard’s device might have given a clue that the agency would look on it with favour.
The paclitaxel-coated device, approved in the US for femoropopliteal occlusive disease – blockages in arteries in the thigh or knee – will be one of Bard’s key growth drivers. Analysts from Brean Capital forecast $50m in revenues from Lutonix in 2015, but this assumed a January release. Earlier approval could mean the device sells more.
Only one option
Bard having beaten Medtronic to the US is perhaps surprising since Medtronic’s device had been on sale in Europe for nearly two years before Lutonix arrived there. But the battle for market share in both areas could be fierce.
IN.PACT Admiral has posted some impressive clinical results, with the IN.PACT SFA trial yielding the lowest 12-month clinically driven target lesion revascularisation rate for any peripheral intervention ever studied, at 2.4%.
But Bard’s device has shown similar effectiveness with lower paclitaxel dosage, and its pivotal trial is acknowledged as more rigorously designed. FDA approval of Lutonix was based on the Levant 2 study, in which the proportion of vessels that remained open for one year was 73.5%, compared with 56.8% for standard angioplasty. The trial was single-blind, which might give Bard an advantage – of the two pivotal trials of IN.PACT Admiral, Inpact SFA I and II, only one was single-blind with the other being open-label.
The data on Medtronic’s balloon are almost certainly strong enough for it to gain approval, after which interventional cardiologists will be able to choose between the devices. But for now only one option is available, and Bard will have to capitalise on its exclusivity while it can.
|Inpact SFA I||NCT01175850|
|Inpact SFA II||NCT01566461|