FDA Issues Safety Alert For Absorb GT1 Bioresorbable ... | 合法醫療器材資訊網

2017年3月18日—TheU.S.FoodandDrugAdministration(FDA)hasissuedasafetyalertfortheAbsorbGT1BioresorbableVascularScaffold(BVS)byAbbott ...

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[1] 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 analys...