(Updated)
Abbott Laboratories has 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. Last week fresh fuel was added to the fire with the announcement that another randomized trial, AIDA, had been terminated early by the data and safety monitoring board because of an increase in stent thrombosis, including late stent thrombosis.
In its letter Abbott said the restrictions will become effective on May 31 and that it plans to review the situation next summer. The company said it is “working jointly with the European Regulatory Agencies.” Among other issues the registry hopes to “address questions” concerning stent thrombosis, duration of dual antiplatelet therapy (DAPT) after implantation, and implantation technique.
At the time of writing there is no news available about the status of Absorb in the US.
News about the letter surfaced recently on Twitter and included a copy of the Abbott letter (see below, click to enlarge the images). One interventional cardiologist, who tweets as @Jeddacath, commented:
“The right way to introduce a new device in the first place. Limit only to registries & clinical trials before use in the wild.”
This story will be updated as more information becomes available.
Update:
Jonathan Reiner (George Washington University) tweeted:
“We removed Absorb from our lab a week ago. How can Abbott continue to market the device in US when it’s restricted in Europe? Very bad idea.”
Abbott sent the following comment:
Post-marketing registries are being initiated in Europe to monitor implantation technique for the Absorb dissolving stent. These EU registries will parallel post-approval observational studies and training being conducted in other parts of the world, including the ABSORB IV study of 3,000 patients in the United States, to confirm the effect of current implantation technique on clinical outcomes. Analyses of ABSORB trials from around the world have demonstrated that optimal implantation technique for Absorb results in outcomes comparable to the best-in-class metallic drug eluting stent, with the added feature of leaving no metal behind once it dissolves.
Abbott sent this additional clarification about the regulatory status of the device in Europe and the status of Absorb in the US:
Absorb is not being pulled, nothing has changed with the product’s regulatory status, and it continues to be commercially available through the registries.
Regarding the US, Absorb continues to be available to doctors who have completed the required training. Since FDA approval last year, Abbott requires physicians to undergo comprehensive training before they are able to implant Absorb to ensure proper implantation techniques.
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