drug coated balloons for pad william b. newton iii, md assistant professor of surgery department of...

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Drug Coated Balloons for PAD William B. Newton III, MD Assistant Professor of Surgery Department of Vascular and Endovascular Surgery

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Page 1: Drug Coated Balloons for PAD William B. Newton III, MD Assistant Professor of Surgery Department of Vascular and Endovascular Surgery

Drug Coated Balloons for PAD

William B. Newton III, MDAssistant Professor of Surgery

Department of Vascular and Endovascular Surgery

Page 2: Drug Coated Balloons for PAD William B. Newton III, MD Assistant Professor of Surgery Department of Vascular and Endovascular Surgery

Contents

Introduction PAD Burden Anatomy of a Drug

Coated Balloon LUTONIX® 035 Device

Overview Product Offering

Procedure Steps

LUTONIX® 035 Treatment Algorithm

LUTONIX® 035 Pre-Clinical Evidence

LEVANT2ClinicalTrial LEVANT2ClinicalCase

Studies Resources

Page 3: Drug Coated Balloons for PAD William B. Newton III, MD Assistant Professor of Surgery Department of Vascular and Endovascular Surgery

Introduction

DCB available: LUTONIX® 035 Drug Coated Balloon is the first and

ONLY of its kind technology in the U.S. that can advance our treatment algorithm for SFA/Popliteal disease.

Others are in the process of obtaining FDA approval.

Page 4: Drug Coated Balloons for PAD William B. Newton III, MD Assistant Professor of Surgery Department of Vascular and Endovascular Surgery

Peripheral Artery Disease Impact

Page 5: Drug Coated Balloons for PAD William B. Newton III, MD Assistant Professor of Surgery Department of Vascular and Endovascular Surgery

Anatomy of DCB

Page 6: Drug Coated Balloons for PAD William B. Newton III, MD Assistant Professor of Surgery Department of Vascular and Endovascular Surgery

DCB Formulation

Page 7: Drug Coated Balloons for PAD William B. Newton III, MD Assistant Professor of Surgery Department of Vascular and Endovascular Surgery

DCB Development

Page 8: Drug Coated Balloons for PAD William B. Newton III, MD Assistant Professor of Surgery Department of Vascular and Endovascular Surgery

DCB Design

Page 9: Drug Coated Balloons for PAD William B. Newton III, MD Assistant Professor of Surgery Department of Vascular and Endovascular Surgery

DCD Carriers

Page 10: Drug Coated Balloons for PAD William B. Newton III, MD Assistant Professor of Surgery Department of Vascular and Endovascular Surgery

DCB Coating Integrity

Page 11: Drug Coated Balloons for PAD William B. Newton III, MD Assistant Professor of Surgery Department of Vascular and Endovascular Surgery

DCB Coating Integrity

Page 12: Drug Coated Balloons for PAD William B. Newton III, MD Assistant Professor of Surgery Department of Vascular and Endovascular Surgery

DCB Coating Uniformity

Page 13: Drug Coated Balloons for PAD William B. Newton III, MD Assistant Professor of Surgery Department of Vascular and Endovascular Surgery

DCB Coating Uniformity

Page 14: Drug Coated Balloons for PAD William B. Newton III, MD Assistant Professor of Surgery Department of Vascular and Endovascular Surgery

DCB Mechanism of Action

Page 15: Drug Coated Balloons for PAD William B. Newton III, MD Assistant Professor of Surgery Department of Vascular and Endovascular Surgery

DCB Preclinical Safety Data

Page 16: Drug Coated Balloons for PAD William B. Newton III, MD Assistant Professor of Surgery Department of Vascular and Endovascular Surgery

DCB Preclinical Safety Data

Page 17: Drug Coated Balloons for PAD William B. Newton III, MD Assistant Professor of Surgery Department of Vascular and Endovascular Surgery

DCB: LEVANT 2

Page 18: Drug Coated Balloons for PAD William B. Newton III, MD Assistant Professor of Surgery Department of Vascular and Endovascular Surgery

DCB: LEVANT 2

Page 19: Drug Coated Balloons for PAD William B. Newton III, MD Assistant Professor of Surgery Department of Vascular and Endovascular Surgery

DCB: LEVANT 2

Page 20: Drug Coated Balloons for PAD William B. Newton III, MD Assistant Professor of Surgery Department of Vascular and Endovascular Surgery

DCB: LEVANT 2

Page 21: Drug Coated Balloons for PAD William B. Newton III, MD Assistant Professor of Surgery Department of Vascular and Endovascular Surgery

DCB: LEVANT 2

Page 22: Drug Coated Balloons for PAD William B. Newton III, MD Assistant Professor of Surgery Department of Vascular and Endovascular Surgery

DCB: LEVANT 2

Page 23: Drug Coated Balloons for PAD William B. Newton III, MD Assistant Professor of Surgery Department of Vascular and Endovascular Surgery

DCB: LEVANT 2

Page 24: Drug Coated Balloons for PAD William B. Newton III, MD Assistant Professor of Surgery Department of Vascular and Endovascular Surgery

DCB: LEVANT 2

Page 25: Drug Coated Balloons for PAD William B. Newton III, MD Assistant Professor of Surgery Department of Vascular and Endovascular Surgery

DCB: LEVANT 2

Page 26: Drug Coated Balloons for PAD William B. Newton III, MD Assistant Professor of Surgery Department of Vascular and Endovascular Surgery

DCB IFU

Page 27: Drug Coated Balloons for PAD William B. Newton III, MD Assistant Professor of Surgery Department of Vascular and Endovascular Surgery

DCB Offering

Page 28: Drug Coated Balloons for PAD William B. Newton III, MD Assistant Professor of Surgery Department of Vascular and Endovascular Surgery

DCB Treatment Considerations

Page 29: Drug Coated Balloons for PAD William B. Newton III, MD Assistant Professor of Surgery Department of Vascular and Endovascular Surgery

DCB Procedure

Page 30: Drug Coated Balloons for PAD William B. Newton III, MD Assistant Professor of Surgery Department of Vascular and Endovascular Surgery

DCB Procedure Steps

Page 31: Drug Coated Balloons for PAD William B. Newton III, MD Assistant Professor of Surgery Department of Vascular and Endovascular Surgery

DCB Procedure Steps

Page 32: Drug Coated Balloons for PAD William B. Newton III, MD Assistant Professor of Surgery Department of Vascular and Endovascular Surgery

DCB Procedure Steps

Page 33: Drug Coated Balloons for PAD William B. Newton III, MD Assistant Professor of Surgery Department of Vascular and Endovascular Surgery

DCB: Antiplatelet Regimen

Page 34: Drug Coated Balloons for PAD William B. Newton III, MD Assistant Professor of Surgery Department of Vascular and Endovascular Surgery

DCB: Summary

Page 35: Drug Coated Balloons for PAD William B. Newton III, MD Assistant Professor of Surgery Department of Vascular and Endovascular Surgery

DCB: Case 1

Page 36: Drug Coated Balloons for PAD William B. Newton III, MD Assistant Professor of Surgery Department of Vascular and Endovascular Surgery

DCB: Case 2

Page 37: Drug Coated Balloons for PAD William B. Newton III, MD Assistant Professor of Surgery Department of Vascular and Endovascular Surgery

DCB: Case 3

Page 38: Drug Coated Balloons for PAD William B. Newton III, MD Assistant Professor of Surgery Department of Vascular and Endovascular Surgery

DCB: Case 4

Page 39: Drug Coated Balloons for PAD William B. Newton III, MD Assistant Professor of Surgery Department of Vascular and Endovascular Surgery

DCB: Case 5

Page 40: Drug Coated Balloons for PAD William B. Newton III, MD Assistant Professor of Surgery Department of Vascular and Endovascular Surgery

DCB: Case 6

Page 41: Drug Coated Balloons for PAD William B. Newton III, MD Assistant Professor of Surgery Department of Vascular and Endovascular Surgery

DCB: Questions

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