Normal view MARC view ISBD view

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

MedStar author(s):

Citation: Jacc: Cardiovascular Interventions. 9(17):1757-64, 2016 Sep 12PMID: 27609249Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: *Absorbable Implants | *Advisory Committees | *Cardiovascular Agents/ad [Administration & Dosage] | *Coated Materials, Biocompatible | *Coronary Artery Disease/th [Therapy] | *Device Approval | *Everolimus/ad [Administration & Dosage] | *Percutaneous Coronary Intervention/is [Instrumentation] | *United States Food and Drug Administration | Cardiovascular Agents/ae [Adverse Effects] | Clinical Trials as Topic | Coronary Artery Disease/dg [Diagnostic Imaging] | Equipment Safety | Everolimus/ae [Adverse Effects] | Evidence-Based Medicine | Humans | Patient Safety | Percutaneous Coronary Intervention/ae [Adverse Effects] | Prosthesis Design | Risk Assessment | Time Factors | Treatment Outcome | United StatesYear: 2016 Local holdings: Available online through MWHC library: 2008 - presentISSN:

1936-8798

Name of journal: JACC. Cardiovascular interventionsAbstract: 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.CONCLUSIONS: Following panel discussions and the evidence presented, the panel voted for approval of the device.Copyright c 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.METHODS: Observational report of the FDA Circulatory System Device Panel pre-market approval application meeting held on March 15, 2016.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.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.All authors: Rogers T, Steinvil A, Torguson R, Waksman RFiscal year: FY2017Digital Object Identifier:

https://dx.doi.org/10.1016/j.jcin.2016.06.027

Date added to catalog: 2017-05-24

Holdings ( 1 )
Title notes ( 8 )

Holdings
Item type	Current library	Collection	Call number	Status	Date due	Barcode
Journal Article	MedStar Authors Catalog	Article	27609249	Available		27609249

Available online through MWHC library: 2008 - present

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.

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

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

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.

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.

English