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Overview of the 2014 Food and Drug Administration Circulatory System Devices Panel meeting regarding the Lutonix drug coated balloon.

MedStar author(s):

Citation: Cardiovascular Revascularization Medicine. 15(8):402-7, 2014 Nov-Dec.PMID: 25499024Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleSubject headings: *Angioplasty, Balloon/is [Instrumentation] | *Peripheral Arterial Disease/su [Surgery] | *Vascular Access Devices | Equipment Design | Humans | Treatment Outcome | United States | United States Food and Drug Administration | Vascular Access Devices/st [Standards]Local holdings: Available in print through MWHC library: 2002 - presentISSN:

1878-0938

Abstract: The Lutonix drug coated balloon (DCB) is a combination device composed of a standard percutaneous angioplasty balloon coated with paclitaxel. Depending on the balloon size, a dose density of 2mug/mm(2) yields a variable total dose raging from 1.5mg to 3.8mg. This drug coated balloon aims to provide improved patency rates in patients with symptomatic femoropopliteal de novo or restenotic atherosclerotic disease. On June 12, 2014, the Food and Drug Administration's (FDA) Circulatory System Devices Panel reviewed the Lutonix DCB premarket approval application (PMA). This PMA application was primarily based on data from the pivotal randomized, controlled and multicenter clinical trial, which compared the Lutonix DCB with PTA. This summary aims to describe the discussions and recommendations made by the advisory panel during the meeting. Based on the Panel's recommendations, it is possible that the FDA will approve this device. Copyright � 2014 Elsevier Inc. All rights reserved.All authors: Escarcega RO, Waksman RDigital Object Identifier:

http://dx.doi.org/10.1016/j.carrev.2014.10.006

Date added to catalog: 2016-01-13

Holdings ( 1 )
Title notes ( 3 )

Holdings
Item type	Current library	Collection	Call number	Status	Date due	Barcode
Journal Article	MedStar Authors Catalog	Article		Available		25499024

Available in print through MWHC library: 2002 - present

The Lutonix drug coated balloon (DCB) is a combination device composed of a standard percutaneous angioplasty balloon coated with paclitaxel. Depending on the balloon size, a dose density of 2mug/mm(2) yields a variable total dose raging from 1.5mg to 3.8mg. This drug coated balloon aims to provide improved patency rates in patients with symptomatic femoropopliteal de novo or restenotic atherosclerotic disease. On June 12, 2014, the Food and Drug Administration's (FDA) Circulatory System Devices Panel reviewed the Lutonix DCB premarket approval application (PMA). This PMA application was primarily based on data from the pivotal randomized, controlled and multicenter clinical trial, which compared the Lutonix DCB with PTA. This summary aims to describe the discussions and recommendations made by the advisory panel during the meeting. Based on the Panel's recommendations, it is possible that the FDA will approve this device. Copyright � 2014 Elsevier Inc. All rights reserved.

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