【体外膜肺ECMO精品课件】 Update on New INTERMACSNIH Initiati

IDE Applications
IDE Approvals (Contingent on FDA Decision)
2010
2011
2012
2013
Pre-Clinical Awards
✓DCCC RFP
2012
2013
DCCC Award
2014
2015
Clinical Trial
2016
2017
University of Pittsburgh Children’s Hosp. of Pittsburgh, U. of Pitt. Children’s Hosp. of Pittsburgh, U. of Pitt. Jarvik Heart, Inc. University of Maryland-Baltimore Medical Center Thoratec, Inc. Ension, Inc. Ension, Inc. Ension, Inc.
PumpKIN Program Timeline
Pre-IDE Submission HUD Designation Requests IDE Applications IDE Approvals (Contingent on FDA Decision)
2010
2011
2012
2013
Pre-Clinical Awards
Boston Children’s Hospital Pharos, LLC Washington University in St. Louis Children’s Hospital of Philadelphia University of Alberta, Stollery Children’s Hospital Texas Children’s Hospital University of Arkansas for Medical Sciences University of Alabama-Birmingham University of Michigan Stanford University Children’s Hospital of Philadelphia
• Hypothesis: Survival and rates of SAE’s equal to or better than historical or concurrent controls.
PumpKIN Program Timeline
✓Pre-IDE Submission ✓HUD Designation Requests
Proposed PumpKIN Trials
• Multi-Center Single-Arm Trials. One for each device • Similar patient sample size used in Berlin Heart Trial (N=30) • Follow-up
– VADs: 12 months – ACE Systems: 6 months
• Endpoints
– Primary: Survival to TX, Recovery, Death – Safety: Frequency of SAE’s, device-related AE’s, infections, and bleeding – Secondary Endpoints: Neuro-development and QOL
IDE Applications
IDE Approvals (Contingent on FDA Decis2013
Pre-Clinical Awards
✓DCCC RFP
PumpKIN Program Timeline
✓Pre-IDE Submission ✓HUD Designation Requests
Eligible Devices: Circulatory support devices appropriate for small children (<25 kg) with heart disease who experience cardiopulmonary failure and circulatory collapse.
PumpKIN Pre-Clinical Program
Four-year contracts. Began in January, 2010
Objective: To obtain IDEs for circulatory assist devices for infants and/or small children
March 12th, 2012 Crown Plaza Washington Airport, Arlington, VA
Tim Baldwin, Ph.D.
Deputy Chief, Advanced Technologies and Surgery Branch Basic and Early Translational Research Program Division of Cardiovascular Sciences NHLBI
• Collaboration with contractors and industry sponsors • 66-month Contract • Targeted to start April, 2012
PumpKIN Protocol Development Committee
(Independent Members)
DCCC RFP
Program
pCAS ➢Ension, Inc.
PI: Mark Gartner, Ph.D.
Jarvik Pediatric 2000 VAD ➢Jarvik Heart, Inc.
PI: Robert Jarvik, M.D.
PediPL ➢Univ. Maryland➢Baltimore Med. Ctr. ➢Thoratec
PediPL Initial In-vivo Animal Study
Explanted Devices
PPL09 after 32 days
PPL08 after 30 days
Jarvik 2000 Pediatric VAD
•Implantable •No Pump Pocket •Versatile Positioning •Out-of-Hospital Use •Long-Term Support •Human-Engineered Controller
PI: Barley Griffith, M.D.
PediaFlow ➢U. Pittsburgh ➢Children’s Hosp. of Pittsburgh ➢CMU ➢WorldHeart, Inc. ➢LaunchPoint
PI: Harvey Borovetz, Ph.D.
Pediatric Cardiopulmonary Assist System (pCAS)
• Pedro del Nido, MD (Chair) • Kurt Dasse, PhD • Deirdre Epstein, RN • Rebecca Ichord, MD • Patricia Massicotte, MD • David Morales, MD • Robert Morrow, MD • David Naftel, PhD • Richard Ohye, MD • David Rosenthal, MD • Robert Shaddy, MD
PediaFlow
PumpKIN Data and Clinical Coordinating Center (DCCC)
• Work includes
– Developing Clinical Protocol(s) & Related Forms – Developing Monitoring Procedures – Providing Safety Oversight – Coordinating Clinical Sites – Implementing and Conducting Clinical Study – Training & Supporting Sites – Analyzing and Disseminating Data – Providing FDA Documentation for HDE Applications
Work includes: • Pre-clinical testing and analysis • Developing manufacturing documentation • Regulatory, technical, and clinical support • Submitting pre-IDE, request for HUD, & IDE application • Collaborating with DCCC and other contractors on Clinical Trial
【体外膜肺ECMO精品课件】 Update on New INTERMACSNIH Initiatives
6th Annual INTERMACS Meeting NHLBI
Pumps for Kids, Infants, and Neonates (PumpKIN) Program Update
PumpKIN Protocol Development Committee
(Contract Team Members)
• Harvey Borovetz, PhD • Peter Wearden, MD, PhD • Steven Webber, MD • Robert Jarvik, MD • Bartley Griffith, MD • Barry Gellman, MS • Mark Gartner, PhD • Greg Johnson, PhD • Joseph Tamblyn, CCP