Navigation Links
FDA Advisory Panel Unanimously Recommends Approval of EXCOR(R) Pediatric Ventricular Assist Device for Use in the United States
Date:7/26/2011

BERLIN and THE WOODLANDS, Texas, July 26, 2011 /PRNewswire/ --

 

At the request of Dr. Bram Zuckerman, Director, Division of Cardiovascular Devices, Center for Devices and Radiologic Health of the United States Food and Drug Administration, a special panel was convened on Thursday July 21 in Gaithersburg, Maryland to review the results of the EXCOR® IDE clinical trial.  The specific charge of the panel was to review the clinical data from the trial and to make recommendations to the FDA concerning the safety and probable benefit of the EXCOR® VAD as it pertains to an application for Humanitarian Device Exemption (HDE) approval. This 22 member panel was comprised of a group of experts in pediatric and adult cardiology, pediatric and adult cardiac surgery, neurology, biostatistics, and other areas of expertise.  It also included patient, consumer, and industry representatives. The panel was chaired by Dr. Clyde Yancy, Chief of the Division of Cardiology at Northwestern University School of Medicine in Chicago, Illinois.  

In preparation for presenting the study results to the panel, a team representing Berlin Heart and the investigation was assembled.  Working together over several months, including several face to face meetings, this group, now affectionately termed the Berlin Heart "Dream Team", worked very hard to be well prepared. The main presentation and the bulk of the clinical data and trail results was presented to the Panel by the National Principal Investigator of the study, Charles D. Fraser, Jr., M.D., FACS, Surgeon-in-Chief, Clayton Chair in Surgery, Donovan Chair and Chief, Congenital Heart Surgery, Texas Children's Hospital and Professor of Surgery and Pediatrics, Baylor College of Medicine and Charles E. Canter, M.D. Medical Director, Heart Failure/Transplant Program / St. Louis Children's Hospital, and Professor of Pediatrics, Washington University School of Medicine.  Dr. Fraser and Dr. Canter were supported by Rebecca Ichord, M.D., Lori Jordan, M.D., James Tweddell, M.D., David Rosenthal, M.D.,  Robert Jaquiss, M.D., Peter Wearden, M.D., Elaine Cox, M.D., Patti Massicotte, M.D., Tilman Humpl, M.D., David Naftel, PhD., and Chris Almond, M.D. Supporting the Investigators and Advisors from Berlin Heart were Bob Kroslowitz, VP Clinical Affairs, Mary Beth Kepler, VP Regulatory Affairs and Quality Assurance, and Christine Tjossem Director of Statistical Operations.

The events of the day culminated in the public forum vote by the panel on the questions of EXCOR® device safety and probable benefit.  In a thrilling process, the panel members voted unanimously in favor of HDE approval.  The commentary from each panel member proved insightful and supportive.  This was an emotional and very gratifying experience for all of those in attendance.

Dr. Fraser commented, "This is an enormous step forward for children with heart failure.  I would like to personally thank all of the individuals who have been so supportive of this difficult and important study; people from across the United States, Canada and from Germany.  We have all worked together to establish a new precedent for our patients."

The following US centers participated in the IDE study:

  • Arkansas Children's Hospital (AR)
  • Boston Children's Hospital (MA)
  • Children's Healthcare of Atlanta (GA)
  • Children's Hospital of Wisconsin (WI)
  • The Children's Hospital of Denver (CO)
  • Lucille Packard Children's Hospital at Stanford (CA)
  • Mott Children's Hospital (MI)
  • Mount Sinai Hospital (NY)
  • Pittsburgh Children's Hospital (PA)
  • Riley Children's Hospital (IN)
  • Seattle Children's Hospital (WA)
  • St. Louis Children's Hospital (MO)
  • Texas Children's Hospital (TX)
  • Children's Hospital at the University of Alabama (AL)
  • University of Minnesota at Fairview (MN)

Dr. Stefan Thamasett, CEO of the Berlin Heart Group, commented, "The Panel's unanimous decision represents another major milestone for the Berlin Heart Group in bringing this important lifesaving technology to the pediatric population. Completing this historical, first ever prospective controlled clinical trail for Ventricular Assist Devices in children is a major achievement for both Berlin Heart and the Medical Community."

While Berlin Heart awaits the final decision of the FDA, Implants of the Berlin Heart EXCOR® Pediatric Ventricular Assist Device in the US for BTT patients are continuing under a Continued Access Protocol approved by the FDA.

About Berlin Heart:

Berlin Heart GmbH is the only company worldwide that develops, produces, and distributes

implantable and external ventricular assist devices for patients of every age and body size.

The company offers pumps, cannulae, and external components for internal and external use to stabilize cardiac activity in acutely ill patients. Its products are market leaders in their respective segments in Germany and in Europe.

The company also manufactures the implantable left ventricular assist device INCOR®, which has been designed for long-term application in adult patients. The longest the device has supported a patient so far is more than five years and ongoing. INCOR® is not FDA-approved, but widely used in Europe.

Berlin Heart Inc., the company's US subsidiary, was founded in 2005 to support the North

American centers. Further product information is available from the company website:

http://www.berlinheart.com.

Contact:

Berlin Heart Inc.
Robert Kroslowitz
200 Valleywood
Suite A500
The Woodlands, TX  77380
kroslowitz@berlinheart.com


Berlin Heart GmbH
Kerstin Unkel
Marketing & PR    
Wiesenweg 10
12247 Berlin        
href="mailto:unkel@berlinheart.de">unkel@berlinheart.de
+49(030)8187-2708



'/>"/>
SOURCE Berlin Heart GmbH
Copyright©2010 PR Newswire.
All rights reserved

Related biology technology :

1. Laszlo Radvanyi, Ph.D. Joins Genesis Biopharma Scientific and Medical Advisory Board
2. Oramed Pharmaceuticals Appoints Dr. Michael Berelowitz as Chairman of Scientific Advisory Board
3. GeneLink Biosciences Expands its Scientific Advisory Board to Support New Product Lines
4. Biomatrica Announces the Appointment of Dr. James A. Robb as a Member of the Scientific Advisory Board
5. Patrick Hwu, M.D., and Mario Sznol, M.D., Join Genesis Biopharmas Scientific and Medical Advisory Board
6. Governor Gray Davis Joins Genesis Biopharma as Chairman of Corporate Advisory Board
7. FDA Advisory Committee Recommends US Approval of Novartis Once-daily Bronchodilator QAB149 for COPD
8. Myriant Technologies, Inc. Announces J. Brian Ferguson to Join Advisory Board
9. Sensus Healthcare Announces the Formation of a Medical Advisory Board
10. Max Neeman International Initiates Advisory Committee to Advance and Improve the Conduct of Complex Neurological Trials in India
11. Leading Dental Stem Cell and Regenerative Medicine Researcher Dr. George Huang Joins StemSaves Science Advisory Council
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/11/2017)... ... October 11, 2017 , ... Proscia Inc ., a ... Webinar titled, “Pathology is going digital. Is your lab ready?” with Dr. Nicolas ... practices and how Proscia improves lab economics and realizes an increase in diagnostic ...
(Date:10/11/2017)... ... October 11, 2017 , ... Disappearing forests and increased ... of over 5.5 million people each year. Especially those living in larger cities are ... - based in one of the most pollution-affected countries globally - decided to take ...
(Date:10/10/2017)... ... ... San Diego-based team building and cooking events company, Lajollacooks4u, has unveiled a ... new look is part of a transformation to increase awareness, appeal to new markets ... It will also expand its service offering from its signature gourmet cooking classes and ...
(Date:10/10/2017)... , ... October 10, 2017 , ... Dr. Bob Harman, ... his local San Diego Rotary Club. The event entitled “Stem Cells ... and had 300+ attendees. Dr. Harman, DVM, MPVM was joined by two human ...
Breaking Biology Technology:
(Date:5/16/2017)... , May 16, 2017  Veratad Technologies, LLC ... of online age and identity verification solutions, announced today ... Identity Conference 2017, May 15 thru May 17, 2017, ... Building and International Trade Center. Identity ... globe and in today,s quickly evolving digital world, defining ...
(Date:4/18/2017)... Calif. , April 18, 2017  Socionext Inc., a global ... of a media edge server, the M820, which features the company,s ... recognition software provided by Tera Probe, Inc., will be showcased during ... at the NAB show at the Las Vegas ... ...
(Date:4/11/2017)... 11, 2017 Research and Markets has announced ... report to their offering. ... global eye tracking market to grow at a CAGR of 30.37% ... Tracking Market 2017-2021, has been prepared based on an in-depth market ... landscape and its growth prospects over the coming years. The report ...
Breaking Biology News(10 mins):