The FDA's Circulatory System Devices Advisory panel has unanimously recommended the US approval of Bard's Lutonix drug-coated balloon (DCB). This is huge news in the US peripheral vascular (PV) market, where physicians have long been waiting to get their hands on DCB technology (which has been available in Europe since 2009).
It is also huge news for Bard, who will gain a first-mover advantage on a hotly anticipated market. Bard picked up its DCB through the late-2011 acquisition of Lutonix a smart move for a company that has been making strides to round out and solidify its lower-extremity product profile. The Lutonix DCB is expected to enter the US market by the end of this year (let's hope it doesn't suffer the same panel-to-approval lag as the Zilver PTX). DRG expects that the lower-extremity DCB market to reach a value of approximately $125 million in the US by 2022.
Ahead of the panel meeting, the FDA voiced concerns that the Lutonix did not meet all of its endpoints in Bard's LEVANT 2 trial. Outcomes of the per-protocol analysis (which excluded patients for whom protocol or exclusion criteria were violated) were not significantly different between the DCB and non-DCB groups. However, safety and efficacy data from the trial was ultimately considered sufficient for the recommendation for approval.
Furthermore, although they are not yet available to commercially benefit from the buzz, DCBs have been buoyed by widespread enthusiasm and optimism about the technology. Until recently, there has been little data to support the clinical usefulness of DCBs but even in the absence of data, physicians want DCBs to succeed. Physicians interviewed by DRG like that the technology can be used on its own, doesn't leave a permanent device behind, and doesn't require use of antiplatelet therapy. DCBs have managed to gain a foothold in Europe, largely based on physician preferences and perceptions alone. This cannot continue without a strong backing of clinical data, and it definitely won't be enough to drive adoption when DCBs become available in the US.
Now, finally, the data is starting to roll in
The LEVANT-2 data that supported the FDA panel's recommendation finally added some solid backing for DCB to the clinical landscape. Furthermore, Medtronic and Covidien both presented positive early data for their respective DCBs at EuroPCR in Paris last month.
Data presented for Medtronic's Admiral DCB was purported to have the highest rate of primary patency and lowest rate of target lesion revascularization (TLR) ever reported at 12 months for peripheral artery disease. This is very exciting 12-month data, and it will be even more exciting to see if these results can hold on (or even improve) in the long-term, where DCBs are expected to drive the most value compared to percutaneous transluminal angioplasty alone.
Early results from Covidien's Stellerex program were equally exciting. A very thorough series of trials were presented, covering drug kinetics, health economics, and results from the first-in-man trial. The first-in-man data was able to drive home the expected long-term benefit of DCB that I alluded to earlier. 4-year data showed NO new clinically driven TLR after one year TLR hit 87.9% at one year and just plateaued. This is a fantastic long-term result that hopefully can be replicated in Covidien's ongoing large-scale trials. The health economic analysis is an extremely relevant add-on in today's value proposition-driven environment. This is especially true for premium-priced devices like DCBs. The fact that Covidien is taking steps to show that higher up-front costs result in long-term savings will position their device to win with hospital administrators, which will be key to success in the US.
After years of buzz and excitement, all of this clinical data and FDA involvement means that the DCB market is finally poised to burst open!