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# FDA Panel Backs Abbott’s Absorbable Drug Eluting Stent
- URL: https://www.fdaweb.com/fda-panel-backs-abbotts-absorbable-drug-eluting-stent/
- Published: 2016-03-16T12:00:00.000Z
- Updated: 2026-09-15T02:44:17.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5135108

> FDA’s Circulatory System Devices Panel has voted 9-0 to recommend approval of an Abbott PMA for the first fully absorbable drug eluting stent. Agency reviewers had determined that clinical data submitted showed that the device was not inferior to a traditional stent, according to a [briefing document](http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/UCM490445.pdf?ref=fdaweb.com) released in advance of the meeting.  
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> The Absorb GT1 Bioresorbable Vascular Scaffold (BVS) System is designed to dissolve within three years after being implanted. During the meeting, of implantation, after restoring blood flow to a blocked artery. While most stents are made of metal, the Absorb stent is made of a naturally dissolvable material. “The unique benefit of Absorb is that it opens the blockage like a metallic stent, but then goes away over time, allowing the artery to return to a more natural state,” the company says.  
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> During voting, the panel agreed 9 to 1 that the device was safe as a treatment for coronary artery disease. On a separate question of whether there is reasonable assurance that the device is efficacious, the vote was 10 to 0 in favor.