FDA says yes to C.R. Bard's DCB
More than 5 years after the first peripheral drug coated balloons (DCB) began to appear in Europe, the US finally has a DCB of its own. C.R. Bard's Lutonix has become the first DCB to receive FDA approval, after receiving a unanimous FDA panel recommendation in June.
We?ve been awaiting this approval for a long time, and no doubt US physicians will be eager to get their hands on this technology. As I have spoken about before, physicians are keen to adopt DCB in hopes that they can avoid leaving a permanent stent in the highly dynamic peripheral arteries.
The big question that we?ll be watching is how DCB adoption will compare to drug eluting stents (DES), which have been on the US market for 2 years now. The diverse nature of peripheral arterial disease (PAD) means there will be some cases where DCB is the best option and others where DES is the better choice. Ultimately, it seems that DCB has a broader value proposition that should allow it to find its way into more cases.
Plus, the Lutonix is only the first in a line of DCB coming to the US market, which will broaden the product category's reach compared to DES. Medtronic is next up: the company's In.Pact Admiral DCB has been granted an expedited approval pathway by the FDA, and Medtronic expects approval by mid-2015. The peripheral vascular (PV) clout of Bard and Medtronic ? which both have extensive portfolios of tie-in PV devices ? will help drive awareness and adoption of their DCBs.
There's no word yet as to whether this approval will come with a dedicated Medicare coverage, as is currently the case for DES. The DES add-on payment was not announced until a year after the device's FDA approval though, so there still time for this to become a reality for DCB. Continuous release of long-term data from Bard's LEVANT 2 and Medtronic's IN.PACT SFA trials (as well as Covidien's ILLUMENATE trial farther down the road) will likely help drive the economic argument for expanded DCB coverage.
In the meantime, this approval will be a huge boost for Bard, as the company scoops a first mover advantage in a highly anticipated market.