Having just returned from TCT 2015, I can say that the vascular medtech market remains extremely dynamic, with active controversies that require additional data to resolve and new technologies continuing to emerge.
Certainly one of the big stories at TCT 2015 was the presentation of the 1 year follow-up from the ABSORB III trial, testing Abbott Laboratories’ Absorb BVS against DES. Encouragingly, this trial demonstrated non-inferiority for the BVS, which will likely tamp down some of the early concern (mostly about the stent thrombosis issue observed in the GHOST-EU registry) about these devices.
Abbott’s big hope is that the 2 year (and later) follow-up in both the ABSORB III as well as the recently announced ABSORB IV trials will eventually demonstrate superiority over conventional DES. Why should it take so long? Because the scaffold has to fully resorb (a process that takes approximately a year) before you can expect to see any additional benefit (with the restoration of native vasomotion being the main talking point).
While there’s a good chance that this proves to be the case, my inner skeptic is already considering the possibility that the Absorb will simply remain non-inferior out as far as Abbott cares to follow the ABSORB cohorts. Why? Well, we can’t lose sight of the fact that current generation DES are extremely good, with negative incidence rates in the single digit range (at least over the first year or two). This is particularly true of the comparator in the ABSORB trial, Abbott’s own XIENCE DES, generally considered best-in-class. Showing an improvement over something that is already highly optimized over successive generations is tough to do.
In other words, this might be an example of hitting the 'good enough' wall. It reminds me of an interesting article I read awhile back that argued that this phenomenon is common, and gave as an example the progression of aviation over the past 100 years, which basically divides into two phases. The first phase (from about 1910 to 1960) involved rapid improvements, basically going from the Wright brother’s balsa wood contraption to the 747. But then? It turned out that really progressing beyond that point, while theoretically possible (e.g., going supersonic, as with the Concorde), was just really expensive and not really worth it for most people.
So are we hitting the 'good enough' wall with current generation DES, or is there still room for another quantum leap forward in the form of something like BVS? Hard to say for sure, but it’s always important to keep in mind that most technologies cannot go on improving exponentially forever; eventually, they simply become dependable (and commoditized). And there’s nothing wrong with that.
Follow Alexander Marsolais on Twitter at @amarsolais_DRG for additional medtech market insights.