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# Safety Concern Continues with Abbott’s Absorb Scaffold: FDA
- URL: https://www.fdaweb.com/safety-concern-continues-with-abbotts-absorb-scaffold-fda/
- Published: 2017-10-31T12:00:00.000Z
- Updated: 2026-09-14T22:59:15.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5140008

An FDA [safety update](https://www.fda.gov/MedicalDevices/Safety/LetterstoHealthCareProviders/ucm582728.htm?ref=fdaweb.com) says that interim study results through three years from a pivotal clinical trial (ABSORB III) continue to show an increased rate of major adverse cardiac events and scaffold thrombosis in patients receiving Abbott Vascular’s [Absorb GT1 Bioresorbable Vascular Scaffold (BVS)](https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm509951.htm?ref=fdaweb.com), when compared to patients treated with the company’s metallic XIENCE drug-eluting stent. Specifically, data show a 13.4% 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 scaffold at three years, compared with 10.4% in patients treated with the XIENCE stent. The update says the company stopped global marketing of the Absorb scaffold last month.