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.
- 2016
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. 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.
English
1936-8798
*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 States
MedStar Heart & Vascular Institute
Journal Article
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. 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.
English
1936-8798
*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 States
MedStar Heart & Vascular Institute
Journal Article