Cardiovascular 2: Pre-Clinical Testing of Novel Cardiovascular Devices
Tuesday, April 10, 2:00-3:30, A.I. Johnson Great Room, McNamara Alumni Center

Organizer: Larry Carrier, Claret Medical, Inc.
Moderator: Michael C. Morton, Senior Director, Global Regulatory Affairs, Medtronic, Inc.

"Considerations for Development of Novel Products"
Declan Dineen, Director, Regulatory Affairs, Medtronic, Inc.

"Interactive Panel Discussion on a 'Widget'”
Michael C. Morton, Senior Director, Corporate Regulatory Affairs, Medtronic, Inc.

"Approach and Methodology for Pre-Clinical Assessments"
John Zentgraf, Vice President, Research and Development, NeoChord, Inc.

"Pre-Clinical Evaluation of Novel Cardiovascular Devices – A Case Study: Transcatheter Heart Valve Substitutes"
Tim Kelley, Senior Principal Product Development Engineer, Medtronic, Inc.

"How an FDA Reviewer Handles Unknowns"
Changfu Wu, PhD, Circulatory Support and Prosthetics Branch, Division of Cardiovascular Devices, Office of Device Evaluation, Center for Devices & Radiological Health, Food and Drug Administration

Session Abstract:

How do you determine the preclinical testing requirements for a new or novel cardiovascular device? This session will address the fundamental questions we should be asking about a devices design, discuss testing approaches and methodologies, trends in the industry and FDA, and early collaboration with regulatory agencies. Case studies will be presented individually or in a panel format.

Session Organizer Bio:

Larry Carrier, Claret Medical, Inc.
Larry Carrier is Vice President, Regulatory, Clinical, and Quality for Claret Medical, Inc. Larry was previously Senior Director, Regulatory Affairs for Medtronic CardioVascular businesses (Endovascular Innovations, Structural Heart) and has held other regulatory affairs and quality positions over the past 20 years at Med-El Elektromedizinische Geraete GmbH, W.L. Gore & Associates, Johnson and Johnson, and Sulzer Orthopedics. Larry serves on the Advisory Board for the Texas A&M Biomedical Engineering Department and is a graduate of Texas A&M University with a Bachelor’s degree in Biomedical Engineering. He also holds an MS in Biomedical Engineering from the University of Texas at Austin. Larry is based in Santa Rosa, CA.

Michael C. Morton, Senior Director, Global Regulatory Affairs, Medtronic, Inc.
Michael has twenty five years of experience in regulatory affairs. Before joining Medtronic, Inc., Michael worked with CarboMedics, Inc.; W.L. Gore and Associates; Alcon Labs; and Sorin Group. Michael is active in industry groups, including the Advanced Medical Technology Association (AdvaMed). Michael is chair of the AdvaMed PMA Working Group, and is a member of the 510(k) Working Group and the Heart Valve Task Force. Currently, Michael represents AdvaMed on Study Group 1 (Premarket) of the Global Harmonization Task Force. Michael has been recognized as a Fellow of the Regulatory Affairs Professional Association (RAPS). He served as the industry representative to the FDA Circulatory System Devices Advisory Panel from 2001 to 2005.

Speaker Bios:

Declan Dineen, Senior Manager, Regulatory Affairs, Medtronic, Inc.
Declan Dineen is a Senior Regulatory Affairs Manager with Medtronic CardioVascular. Declan has provided regulatory support for medical device products from development through commercial life cycle for over 12 years. This includes global commercialization of multiple Class III products including coronary stents, combination products (Drug Eluting Stents) and, most recently, Transcatheter Valve products. Declan is a graduate of Trinity College Dublin University with a Bachelor’s degree in Natural Sciences and also holds an MSC in Toxicology from Athlone Institute of Technology, Ireland. Declan is based in Santa Rosa, CA.

John Zentgraf, Vice President, Research and Development, NeoChord, Inc.
John Zentgraf is Vice President of Research and Development for NeoChord, Inc. NeoChord has developed an instrument for beating heart repair of the mitral valve. Prior to joining NeoChord, John was the Vice President of Research and Development for Guidant Corporation’s CRM division in St. Paul, MN. John has held engineering and management positions at Medtronic and Interconics. John serves on the Board of Directors for Phraxis, Inc. Phraxis is developing a percutaneous delivery system and implantable device for dialysis. John has a Masters in Systems Engineering from the University of St. Thomas and a BS in Biology from Winona State University.

Tim Kelley, Senior Principal Product Development Engineer, Medtronic, Inc.
Tim Kelley is a Senior Principal Product Development Engineer for Medtronic CardioVascular with his primary focus on the development of transcatheter heart valve systems. He has held other development and reliability engineering positions over the past 20 years at Medtronic Cardiac Disease Rhythm Management, Sulzer CarboMedics, and McDonnell Douglas Aerospace. Tim currently serves as co-chair of the ISO 5840 technical committee developing a new international standard for transcatheter heart valves. He also serves as Associate Editor for the Cardiovascular Engineering and Technology journal. Tim holds an MS in Mechanical Engineering from Washington University in St. Louis. He possesses BS degrees in Mechanical Engineering from Washington University and in Applied Mathematics from Phillips University in Enid, OK. Tim is based in Minneapolis, MN.

Changfu Wu, PhD, Circulatory Support and Prosthetics Branch, Division of Cardiovascular Devices, Office of Device Evaluation, Center for Devices & Radiological Health, Food and Drug Administration
Changfu Wu is a scientific reviewer in the Circulatory Support and Prosthetic Devices Branch in the Office of Device Evaluation at the Food and Drug Administration (FDA). Changfu obtained his Doctoral Degree in Mechanical Engineering in 2003 from the Center for Applied Stochastics Research at Florida Atlantic University with a dissertation in heart valve durability research. Prior to joining FDA in June 2009, he completed his post-doctoral training in joint biomechanics at the Musculoskeletal Research Center at University of Pittsburgh, and worked on circulatory assist devices at the Artificial Organs Laboratory of University of Maryland School of Medicine.

Presentation Abstracts:

"Considerations for Development of Novel Products"
What’s involved in taking a novel product from concept to market? Who are the regulatory agencies, how does a company engage with them and what do they want to know? This presentation will focus on the regulatory process, outline key regulatory considerations when developing a novel product and identify best practices when working with regulatory agencies.

"How an FDA Reviewer Handles Unknowns"
An innovative medical device design is often associated with some degree of uncertainties, some of which we know (i.e., known unknowns) and some of which we do not know (i.e., unknown unknowns). This talk discusses, from an FDA reviewer's perspective, how we might tackle those uncertainties during preclinical evaluation of the device.

Related Sessions:

Cardiovascular 1 Cardiac Keynote Presentations
Cardiovascular 3 Cardiovascular Modeling
Cardiovascular 4 Cardiac Electrophysiology and Mapping
Cardiovascular 5 Cardiac Ablative Therapies
Cardiovascular 6 Cardiac Devices in the Pediatric Population