MedStar Authors catalog › Details for: Overview of the 2016 U.S. Food and Drug Administration Circulatory System Devices Advisory Panel Meeting on the Absorb Bioresorbable Vascular Scaffold System.
Overview of the 2016 U.S. Food and Drug Administration Circulatory System Devices Advisory Panel Meeting on the Absorb Bioresorbable Vascular Scaffold System. Journal: JACC. Cardiovascular interventions.Published: 2016ISSN: 1936-8798.UI/PMID: 27609249.Subject(s): *Absorbable Implants | *Advisory Committees | *Cardiovascular Agents/ad [Administration & Dosage] | Cardiovascular Agents/ae [Adverse Effects] | Clinical Trials as Topic | *Coated Materials, Biocompatible | Coronary Artery Disease/dg [Diagnostic Imaging] | *Coronary Artery Disease/th [Therapy] | *Device Approval | Equipment Safety | *Everolimus/ad [Administration & Dosage] | Everolimus/ae [Adverse Effects] | Evidence-Based Medicine | Humans | Patient Safety | Percutaneous Coronary Intervention/ae [Adverse Effects] | *Percutaneous Coronary Intervention/is [Instrumentation] | Prosthesis Design | Risk Assessment | Time Factors | Treatment Outcome | United States | *United States Food and Drug AdministrationInstitution(s): MedStar Heart & Vascular InstituteActivity type: Journal Article.Medline article type(s): Journal ArticleOnline resources: Click here to access online Digital Object Identifier: https://dx.doi.org/10.1016/j.jcin.2016.06.027 (Click here) Abbreviated citation: JACC Cardiovasc Interv. 9(17):1757-64, 2016 Sep 12.Local Holdings: Available online through MWHC library: 2008 - present.Abstract: OBJECTIVES: 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.Abstract: 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.Abstract: METHODS: Observational report of the FDA Circulatory System Device Panel pre-market approval application meeting held on March 15, 2016.Abstract: 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.Abstract: CONCLUSIONS: Following panel discussions and the evidence presented, the panel voted for approval of the device.Abstract: Copyright c 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.