Abbott Laboratories sent a letter to European physicians informing them that the Absorb Bioresorbable Vascular Scaffold (BVS) and Absorb GT1 BVS “will only be available for use in clinical registry setting at select sites/institutions.”
The company’s action comes in response to an avalanche of bad news for the controversial device. Last fall 3-year results from the ABSORB II trial uncovered a significantly higher rate of target vessel MI. More recently, 2-year results from the pivotal ABSORB III trial confirmed those findings, showing a significant increase in target lesion failure. At the same time the FDA said that it was investigating the stent.
