FDA Issues Warning on Bioresorbable Stents

Absorb GT1 Bioresorbable Vascular Scaffold (BVS) by Abbott Vascular: Letter to Health Care Providers - FDA Investigating Increased Rate of Major Adverse Cardiac Events

fda.gov

The FDA’s initial review of two-year data from the BVS[Absorb GT1 Bioresorbable Vascular Scaffold] pivotal clinical study (the ABSORB III trial) shows an 11 percent rate of major adverse cardiac events (e.g., cardiac death, heart attack, or the need for an additional procedure to re-open the treated heart vessel) in patients treated with the BVS at two years, compared with 7.9 percent in patients treated with the already-approved Abbott Vascular’s metallic XIENCE drug-eluting stent (p = 0.03). This study also shows a 1.9 percent rate of developing blood clots (thrombosis) within the BVS versus 0.8 percent within the XIENCE stent at 2 years.