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# Abbott PMA for Absorbable Stent Shows Non-inferiority: FDA
- URL: https://www.fdaweb.com/abbott-pma-for-absorbable-stent-shows-non-inferiority-fda/
- Published: 2016-03-14T12:00:00.000Z
- Updated: 2026-09-15T02:43:32.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5135061

> An Abbott PMA for the first fully absorbable drug eluting stent contains clinical data showing the device was not inferior to a traditional stent, according to an FDA [briefing document](http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/UCM490445.pdf?ref=fdaweb.com) released in advance of a 3/15 Circulatory System Devices Panel meeting. While clinical data for Abbott’s Absorb GT1 Bioresorbable Vascular Scaffold (BVS) System met the criterion for non-inferiority to the company’s Xience stent, the rates for target vessel myocardial infarction and stent thrombosis were numerically higher in the BVS group vs. the Xience group, the agency says. The absolute difference of the target lesion failure rate between treatment groupswas 1.71% in favor of the Xience group. FDA plans to ask panel members to vote on whether the data demonstrate adequate evidence of clinical non-inferiority to support approval.