Overview of the 2014 Food and Drug Administration Circulatory System Devices Panel meeting regarding the Lutonix drug coated balloon.
Overview of the 2014 Food and Drug Administration Circulatory System Devices Panel meeting regarding the Lutonix drug coated balloon.
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.
English
1878-0938
*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]
MedStar Heart & Vascular Institute
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.
English
1878-0938
*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]
MedStar Heart & Vascular Institute