A lot has been written over the past month or so about the FDA approval of the Absorb bioresorbable vascular scaffold (BVS) – a technology meant to compete with traditional metal coronary stents in the treatment of coronary artery disease (particularly in acute settings for patients suffering from heart attacks). While there is a certain amount of excitement about the long-term potential benefit of a coronary device that resorbs, returning the vessel to more or less its native state, there has also been a fair amount of skepticism about how well this technology will be taken up.
Some of the criticism has focused on the risk of stent thrombosis with the Absorb; my personal feeling is that this concern is largely rooted in older data on the device, and it is likely to recede with time. As discussed at last year’s TCT meeting in San Francisco, while there is some evidence in the most recent randomized data on the Absorb (from the ABSORB III trial) for a higher stent thrombosis rate, that is mostly attributable to device implantation in undersize vessels (particularly those 2.25 mm or smaller).
The larger issue of course is the fact that so far Absorb has failed to show anything other than non-inferiority to the XIENCE DES, and in fact the trend in the one year primary endpoints in ABSORB III favor the XIENCE. This more than anything has people asking themselves whether we will see significant uptake of the Absorb outside of the usual large academic centers.
One major angle on the story that hasn’t been addressed yet (but is always top of mind to a market analyst) is the issue of pricing: what is Abbott going to charge for the device? Or better, what can they get away with charging? In Europe currently, Abbott has managed to maintain a modest premium over DES – although with the EU’s notoriously harsh pricing on DES (particularly in major markets such as Germany), it’s hard to say whether they will be able to justify such a premium in the US.
Another problem for Abbott is Medicare’s recently announced plans to reimburse health care providers a set amount for the treatment of all heart attack patients, regardless of which devices are used and how many procedures need to be performed. This is likely to further embolden purchasers to push for similar pricing on the Absorb as they already paying for DES, especially considering that the block payment would cover all procedures performed in the first 90 days after discharge; all of a sudden, that small increase in stent thrombosis might come to be seen as more important than the (at this point hypothetical) long-term advantage of device resorption.
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