FDA Issues Safety Alert For Absorb GT1 Bioresorbable Vascular Scaffold

The U.S. Food and Drug Administration (FDA) has issued a safety alert for the Absorb GT1 Bioresorbable Vascular Scaffold (BVS) by Abbott Vascular due to an increased rate of major adverse cardiac events observed in patients receiving the device.

The alert comes after the FDA’s initial review of two-year data from the ABSORB III trial that showed an 11 percent rate of major cardiac events (cardiac death, myocardial infarction or the an additional procedure to re-open the treated heart vessel) in patients treated with BVS at two years, compared with 7.9 percent in patients treated with the already approved metallic XIENCE drug-eluting stent, also by Abbott Vascular.

The FDA is working with Abbott Vascular, Inc. to conduct additional analyses and will continue to monitor the performance of the BVS. The full FDA letter to health care providers notes that "an additional preliminary analysis of ABSORB III data suggests improved clinical performance and a lower rate of complications associated with BVS implantation when health care providers follow the recommended implantation methods." The FDA is recommending that health care providers follow the instructions included in the FDA-approved BVS physician labeling regarding selecting appropriately-sized heart arteries for BVS implantation and methods to properly implant the device against the vessel wall. The agency also recommends that BVS patients be advised to follow DAPT recommendations prescribed by their health care providers. Additionally, patients experiencing any new cardiac symptoms such as irregular heartbeats, chest pain, or shortness of breath should be advised to seek clinical care. Any adverse events related to the BVS should be reported through MedWatch.

"While the notion of a bioresorbable scaffold resonates with clinicians and patients alike, until we have large trials demonstrating their clear superiority over existing platforms using drug-eluting stents, we should temper our enthusiasm for using them," said Deepak L. Bhatt, MD, MPH, FACC, senior associate editor of ACC.org and Kim Eagle, MD, FACC, editor-in-chief of ACC.org. This FDA alert provides a strong impetus for a "wait for more data" approach to this debate.

Read more on the alert here.

Clinical Topics: Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention

Keywords: Absorbable Implants, Chest Pain, Coronary Vessels, Drug-Eluting Stents, Dyspnea, Health Personnel, Myocardial Infarction, United States Food and Drug Administration, Cardiology Interventions, Cardiology Magazine


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