Overview of the Virtual 2021 FDA's Circulatory System Devices Advisory Panel on Lutonix 014 Drug-Coated Percutaneous Transluminal Angioplasty Catheter for Below-the-Knee Lesions in Critical Limb Ischemia.

MedStar author(s):
Citation: Cardiovascular Revascularization Medicine. 33:55-61, 2021 12.PMID: 34246613Institution: MedStar Heart & Vascular Institute | MedStar Washington Hospital CenterDepartment: Interventional Cardiology FellowshipForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: *Angioplasty, Balloon | *Cardiovascular System | *Peripheral Arterial Disease | *Pharmaceutical Preparations | *Vascular Access Devices | Angioplasty | Angioplasty, Balloon/ae [Adverse Effects] | Coated Materials, Biocompatible | Humans | Ischemia/su [Surgery] | Limb Salvage | Paclitaxel | Peripheral Arterial Disease/su [Surgery] | Peripheral Arterial Disease/th [Therapy] | Popliteal Artery | Prospective Studies | Treatment Outcome | United States | United States Food and Drug Administration | Vascular PatencyYear: 2021Local holdings: Available in print through MWHC library: 2002 - presentName of journal: Cardiovascular revascularization medicine : including molecular interventionsAbstract: Peripheral artery disease, along with subsequent critical limb ischemia (CLI), is highly prevalent, increases with age, and carries high morbidity and mortality. Specific devices for treatment of below-the-knee (BTK) lesions are limited. On February 17, 2021, the United States Food and Drug Administration convened a virtual meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee to consider a premarket approval application for the Lutonix 014 Drug-Coated Balloon Percutaneous Transluminal Angioplasty Catheter (Becton, Dickinson and Company, Franklin Lakes, New Jersey) for the treatment of obstructive de novo or non-stented restenotic lesions in BTK vessels (popliteal, tibial, and peroneal arteries) in patients with CLI. We summarize the presentations and the panel deliberations, including voting outcome and recommendations for risk versus benefit. Copyright (c) 2021. Published by Elsevier Inc.All authors: Case BC, Torguson R, Waksman R, Zhang COriginally published: Cardiovascular Revascularization Medicine. 2021 Jun 19Fiscal year: FY2022Fiscal year of original publication: FY2021Digital Object Identifier: Date added to catalog: 2021-07-26
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Item type Current library Collection Call number Status Date due Barcode
Journal Article MedStar Authors Catalog Article 34246613 Available 34246613

Available in print through MWHC library: 2002 - present

Peripheral artery disease, along with subsequent critical limb ischemia (CLI), is highly prevalent, increases with age, and carries high morbidity and mortality. Specific devices for treatment of below-the-knee (BTK) lesions are limited. On February 17, 2021, the United States Food and Drug Administration convened a virtual meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee to consider a premarket approval application for the Lutonix 014 Drug-Coated Balloon Percutaneous Transluminal Angioplasty Catheter (Becton, Dickinson and Company, Franklin Lakes, New Jersey) for the treatment of obstructive de novo or non-stented restenotic lesions in BTK vessels (popliteal, tibial, and peroneal arteries) in patients with CLI. We summarize the presentations and the panel deliberations, including voting outcome and recommendations for risk versus benefit. Copyright (c) 2021. Published by Elsevier Inc.

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