Abbott Vascular has restricted the use of its Absorb and Absorb GT1 bioresorbable vascular scaffolds (BVS) in Europe to clinical registries.
Prashant Kaul, MD, an interventional cardiologist and director of the cardiac cath lab at Piedmont Heart Institute in Atlanta, posted on Twitter an urgent field safety notice/physician advisory that Abbott sent to its European customers on March 31.
The letter states that as of May 31, the Absorb will only be available for use in Europe in clinical registry settings. Abbott said it would analyze data from the registries and monitor the technology until the summer of 2018. The company plans on monitoring the effects that implantation techniques and vessel sizing have on clinical outcomes.
Abbott said in the letter that it would stop providing Absorb stents to non-registry sites after March 31. The company added that those non-registry sites should stop implants and remove their existing inventory.
An Abbott spokesperson confirmed the news in an email to Cardiovascular Business.
“Post-marketing registries are being initiated in Europe to monitor implantation technique for the Absorb dissolving stent,” the spokesperson wrote. “Absorb will continue to be commercially available in Europe but through the registries. 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. “
On March 18, the FDA issued a safety alert warning healthcare providers that patients who received the Absorb stent had an increased rate of major adverse cardiac events compared with those who received Abbott’s Xience drug-eluting stent. The FDA approved the Absorb in July 2016 to treat patients with coronary artery disease.
The FDA’s warning was based on the most recent results of the ABSORB III trial, which were presented at the American College of Cardiology scientific session last month.
At two years, 11 percent of patients in the Absorb group and 7.9 percent of patients in the Xience had major adverse cardiac events, which the researchers defined as cardiac death, MI or the need for an additional procedure to re-open the treated heart vessel. The two-year rates of device thrombosis were 1.9 percent in the Absorb GT1 group and 0.8 percent in the Xience group.
The FDA said at the time that it was working with Abbott to better understand why the higher cardiac event and device thrombosis rates occurred in the Absorb group. The agency plans on monitoring the performance of the Absorb stent in clinical trials and reports submitted to the FDA.