Overview of the 2016 U.S. Food and Drug Administration Circulatory System Devices Advisory Panel Meeting on the Absorb Bioresorbable Vascular Scaffold System

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• 作者：Arie Steinvil ; MD ; Toby Rogers ; MD ; Rebecca Torguson ; MPH ; Ron Waksman ; MD ; ^{ron.waksman@medstar.net" class="auth_mail" title="E-mail the corresponding author}
• 关键词：bioresorbable vascular scaffold ; U.S. Food and Drug Administration
• 刊名：JACC: Cardiovascular Interventions
• 出版年：2016
• 出版时间：12 September 2016
• 年：2016
• 卷：9
• 期：17
• 页码：1757-1764
• 全文大小：1006 K

文摘

This study aims to describe the discussions and recommendations made during the U.S. Food and Drug Administration (FDA) Circulatory System Device Panel pre-market approval application for the Absorb Bioresorbable Vascular Scaffold (BVS) System.

Background

The Absorb BVS System is a first-of-its-kind fully bioresorbable percutaneous coronary intervention technology. The absorb BVS was studied in the ABSORB III (A Clinical Evaluation of Absorb BVS, the Everolimus Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects with de Novo Native Coronary Artery Lesions) trial, the pivotal U.S. investigational device exemption trial.

Methods

Observational report of the FDA Circulatory System Device Panel pre-market approval application meeting held on March 15, 2016.

Results

The U.S. FDA Circulatory System Device Panel members reviewed the ABSROB III trial outcomes and additional post hoc analyses presented by the sponsor and the FDA. The ABSORB III trial met the primary endpoint of noninferiority of Absorb BVS compared with the control, XIENCE drug-eluting stent, for target lesion failure at 1 year. Although a higher numerical trend for adverse outcomes was reported for the Absorb BVS, there were no statistical differences between Absorb BVS and XIENCE for any safety or effectiveness components for target lesion failure or for the secondary pre-specified outcomes. Panel members raised concerns with regard to the ABSORB III results and post hoc analyses focusing mainly on the noninferiority design of the trial, the apparent safety issues of the Absorb BVS in small vessels, the mismatch of visually versus intravascular imaging assessed vessel size found in ABSORB III and its implications on the adequate device labeling, the safety of Absorb BVS in specific patient and lesion subsets, and the post-approval commitments of the sponsor.

Conclusions

Following panel discussions and the evidence presented, the panel voted for approval of the device.