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

Slides:

Advertisements

Similar presentations

Single-Patient Use of Investigational Drugs and Biologic Products for Treating Cancer Grant Williams, M.D. Medical Team Leader DODP/CDER/FDA.

Advertisements

Drug Coated Balloons From Bench to Bedside Service de Radiodiagnostic et Radiologie Interventionnelle Université de Lausanne Salah D. Qanadli, MD, PhD,

Single Center Experience with Drug Eluting Stents for Infrapopliteal Occlusive Disease in Patients with Critical Limb Ischemia: Mid-term follow up Robert.

Health Economics & Policy 3 rd Edition James W. Henderson Chapter 13 Technology in Medicine.

Biomedical research methods. What are biomedical research methods? An integrated approach using chemical, mathematical and computer simulations, in vitro.

CR-1 Concluding Remarks and Risk/Benefit Summary Mace L. Rothenberg, MD Professor of Medicine Vanderbilt Ingram Cancer Center.

Cook Zenith® AAA Endovascular Graft and the H&L-B One-Shot  Introduction System P April 10, 2003 FDA Circulatory System Devices Panel Meeting Gaithersburg,

Health Services Organization and Management HSA 500 The Pharmaceutical Industry Williams, S. J., & Torrens, P. R. (2008). Introduction to Health Services.

FDA Office of Orphan Products Development

The implement of ABI/TBI measurement system based on Zigbee technique (PART 2) Presenter: Ying-Tsung Shiau Adviser: Dr. Pei-Jarn Chen Date: 2010/11/03.

September 9, 2002, Circulatory System Devices Panel Meeting FDA Lead Reviewer Summary W.L. GORE & Associates EXCLUDER Bifurcated Endoprosthesis A. Doyle.

Chapter Dental Public Health & Research Contemporary Practice for the Dental Hygienist Copyright ©2011 by Pearson Education, Inc. All rights reserved.

A Comparison of the Moxy™ Drug Coated Balloon Catheter vs. Standard PTA for Femoropopliteal Disease NCT# MONTH RESULTS OF THE LEVANT I TRIAL.

© 2016 Global Market Insights, Inc. USA. All Rights Reserved Fuel Cell Market size worth $25.5bn by 2024Low Power Wide Area Network.

Drug Development Process Stages involved in Regulating Drugs

November 9, 2015 February 20, 2017 Using real world evidence – industry perspective Pma indication expansion Melissa hasenbank, phd Sr. Clinical Research.

Global Experience with Peripheral DCBs/Stent Studies: C.R. Bard

CLI and Device Intervention Across the Pacific – An FDA View

William A. Gray, MD DISCLOSURES Consulting Fees

Endovascular Treatment of Vertebral Artery Stenosis

Patient Focused Drug Development An FDA Perspective

Lutonix® Paclitaxel-Coated Balloon to Treat Obstructive Lesions in the Superficial Femoral and Popliteal Arteries Preliminary Six-Month Results from.

Regulatory Considerations for Coronary Drug Coated Balloons (DCBs)

OneShot™ Renal Denervation System

FDA Pathway to Approval: Clinical Requirements for Renal Denervation

30-Day Safety and Echocardiographic Outcomes Following Transcatheter Aortic Valve Replacement with the Self-Expanding Repositionable Evolut PRO System.

FDA Perspective on Cardiovascular Device Development

THE WINGMAN EXPERIENCE

One DES Eluting Two Drugs: Is it Feasible?

Crossing SFA-Popliteal Artery CTO’s

Patients with abdominal aortic aneurysm: Are we missing the opportunity for cardiovascular risk reduction? G.M. Lloyd, MRCS, J.D. Newton, MRCP, M.G.A.

The progressive nature of peripheral arterial disease in young adults: A prospective analysis of white men referred to a vascular surgery service R.James.

Regulatory Considerations for Coronary Drug Coated Balloons – FDA View

Panelists. Panelists Drug-Coated Balloon for PAD.

Progression After Cancer Immunotherapy in Advanced NSCLC

Optimizing Patient Outcomes in IBD

The management of peripheral vascular complications associated with the use of percutaneous suture–mediated closure devices L.Richard Sprouse, MD, Donald.

Peripheral Arterial Disease: Diagnosis and Management

Understanding PAD.

Drug-Coated Balloons:

Program Goals Overview Glatiramer Acetate 3 Times a Week.

Endovascular Interventions With Carbon Dioxide (CO2) in Renal Transplant Patients With Peripheral Arterial Disease (PAD) Is Safer and Offers Equivalent.

ILLUMENATE Trial design: Patients with superficial femoral artery (SFA) and/or popliteal arterial stenoses were randomized in a 2:1 fashion to either balloon.

Drug-Coated Balloon Angioplasty Confers No Advantage in the Treatment of Femoropopliteal Disease When Stenting Is Required Brian Tiu, MD, Michael Shih,

Factor Xa Inhibitors in PAD

Louis L. Nguyen, MD, MBA, MPH Journal of Vascular Surgery

Long-term safety of cilostazol in patients with peripheral artery disease: The CASTLE study (Cilostazol: A Study in Long-term Effects) William R. Hiatt,

Antithrombotic Therapy in PAD

Comparison of a collagen plug arterial closure device with manual compression after endovascular interventions for peripheral artery disease Talje M.

Collateral artery from arteriovenous malformation of the rectum in a patient with peripheral artery disease Hirotomo Uchiyama, MD, Reiji Hattori, MD,

Can Drug-Coated Balloons Be a Solution for Complex Peripheral Lesions?

Racial and ethnic differences in patterns of treatment for acute peripheral arterial disease in the United States, Vincent L. Rowe, MD, Fred.

Opening an IND: Investigator Perspective

Clinical and economic evaluation of the trellis thrombectomy device for arterial occlusions: preliminary analysis Timur P. Sarac, MD, Daniel Hilleman,

Vincent L. Rowe, MD, William Lee, MD, Fred A

Benefits, morbidity, and mortality associated with long-term administration of oral anticoagulant therapy to patients with peripheral arterial bypass.

The EXercise versus Angioplasty in Claudication Trial (EXACT): Reasons for recruitment failure and the implications for research into and treatment of.

Kim G. Smolderen, PhD, Aline J

The management of peripheral vascular complications associated with the use of percutaneous suture–mediated closure devices L.Richard Sprouse, MD, Donald.

Prevalence of peripheral arterial disease and its association with smoking in a population-based study in Beijing, China Yao He, MD, PhD, Yong Jiang,

Todd R. Vogel, MD, MPH, Robin L. Kruse, PhD

David L. Dawson, MD, Jennifer Meyer, RCIS, Eugene S

Martin E. Harrington, MD, Myron E. Schwartz, MD, Timothy A

Introduction to Basic Research Methods

Clinical Pearls in the Management of Patients With Advanced Non-Small Cell Lung Cancer.

Emily Spangler, Robert W. Chang, Philip P. Goodney

Panelists. Panelists Drug-Coated Balloon for PAD.

Peripheral Vascular Intervention

Navigating the Journey

Endovascular therapy in prevention and management of coronary-subclavian steal Alex Westerband, MD, Julio A Rodriguez, MD, Venkatesh G Ramaiah, MD, Edward.

Presentation transcript:

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

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.

Peripheral Artery Disease Impact

Anatomy of DCB

DCB Formulation

DCB Development

DCB Design

DCD Carriers

DCB Coating Integrity

DCB Coating Uniformity

DCB Mechanism of Action

DCB Preclinical Safety Data

DCB: LEVANT 2

DCB IFU

DCB Offering

DCB Treatment Considerations

DCB Procedure

DCB Procedure Steps

DCB: Antiplatelet Regimen

DCB: Summary

DCB: Case 1

DCB: Case 2

DCB: Case 3

DCB: Case 4

DCB: Case 5

DCB: Case 6

DCB: Questions ??