Navigation Links
Texas Children's Hospital, Lead Study Center, Announces U.S. Food and Drug Administration Approval of EXCOR® Pediatric Ventricular Assist Device for Use in United States
Date:12/16/2011

HOUSTON, Dec. 16, 2011 /PRNewswire/ -- Newborns, toddlers and teens who suffer from heart failure and need heart transplantation to survive just got a life-saving pediatric heart pump that buys time and allows them to grow stronger as they wait for a donor heart.

Texas Children's Hospital in Houston, the lead center in a 17-hospital national Investigational Device Exemption (IDE) study on the German-manufactured Berlin Heart EXCOR Pediatric Ventricular Assist Device (VAD), announced today that the FDA has granted a Humanitarian Device Exemption (HDE) approval for the EXCOR to be used in U.S. children as a bridge to heart transplantation. To watch a video on the significance of the Berlin Heart, please see: http://youtu.be/Gj8gM4MignI.

The EXCOR, used to provide circulatory support to pediatric patients with severe heart failure, is the only VAD approved in the U.S. for use in babies. The pump allows pediatric patients from newborns to teens to remain active so they grow stronger and meet developmental milestones as they await donor hearts.

"I am extremely gratified that the FDA has granted an HDE approval to the EXCOR Pediatric VAD," said Dr. Charles D. Fraser, Jr., surgeon-in-chief at Texas Children's Hospital, professor of surgery and pediatrics at Baylor College of Medicine and national principal investigator for the North American Berlin Heart EXCOR Pediatric study. "This ushers in a new era for children with terminal heart failure. The medical community is now able to offer this life-saving device to support desperate children who would not otherwise survive while awaiting donor hearts. The study involved an incredible effort from 15 U.S. hospitals and two Canadian centers with extensive experience in pediatric heart failure and transplantation. It should serve as a model for future collaborative device studies involving children, industry, medicine and the FDA."

Texas Children's Heart Center implanted its first Berlin Heart on Sept. 27, 2005 in one of the smallest babies to ever receive the device. Brady Burch, a Corpus Christi resident, is now 6 years old and in kindergarten.  Fraser, who has long advocated that babies need small heart assist devices sized just for them, became proactively involved. He accompanied Berlin Heart representatives to Washington, requesting that the FDA allow an IDE study. The FDA agreed to open a study. The first pediatric patient was enrolled in November 2007.

Study background

In January 2008, Texas Children's was named the national lead center for a 12-hospital, 36-month clinical trial of the Berlin Heart EXCOR Pediatric VAD. Fraser was selected as the National Principal Investigator (NPI) for the IDE prospective study. In 2009, five other hospitals were added to the study.

The EXCOR® pediatric clinical study is the first prospective clinical trial ever conducted to investigate the safety and benefit of a VAD in the pediatric population. Between 2007 and 2010, the study enrolled 48 patients in two cohorts of 24 patients each. Another 200 patients were enrolled in a "compassionate use" cohort.  Along with Texas Children's Hospital, the following U.S. 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), Children's Hospital at the University of Alabama at Birmingham (AL), and the University of Minnesota at Fairview (MN).

As NPI, Fraser worked in cooperation with all 17 hospitals in collecting and reporting data to the FDA regarding the safety and probable benefit of the pediatric heart pump. On July 21, 2011, Fraser led the IDE study team as they presented the final data to an FDA circulatory support advisory panel who unanimously recommended that the device be approved by the FDA. The final approval came on Dec. 16, 2011.

"It was a privilege to lead the many investigators, coordinators and administrative personnel involved in this study," said Fraser. "I know the hospitals and physicians who took part did it solely because it was the right thing to do on behalf of children who suffer heart failure."

About Texas Children's Hospital

Texas Children's Hospital, a not-for-profit organization, is committed to creating a community of healthy children through excellence in patient care, education and research. Consistently ranked among the top children's hospitals in the nation, Texas Children's has recognized Centers of Excellence in multiple pediatric subspecialties including the Cancer and Heart Centers, and operates the largest primary pediatric care network in the country. Texas Children's is completing a $1.5 billion expansion, which includes the Jan and Dan Duncan Neurological Research Institute; Texas Children's Pavilion for Women, a comprehensive obstetrics/gynecology facility focusing on high-risk births; and Texas Children's Hospital West Campus, a community hospital in suburban West Houston.  For more information on Texas Children's, go to www.texaschildrens.org. Get the latest news from Texas Children's by visiting the online newsroom and on Twitter at twitter.com/texaschildrens.

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, cannulas, 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.

Contact:
Carol Wittman
832-824-2040 (direct)
713-805-5067 (cell)
cmwittma@texaschildrens.org


'/>"/>
SOURCE Texas Children's Hospital
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Texas to Modernize Medicaid Rx Benefits, Curb Pharmacy Overpayments
2. Heart Hospital of Austin Physician First in Texas to Implant New Heart Failure Device
3. A Heart for Jordan Merecka: Texas Childrens Hospitals First Total Artificial Heart Patient Receives the Gift of a Donor Heart
4. Research Demonstrates Possible Texas Job Losses from Sectors Supported by Biopharmaceutical Companies
5. Vista Imaging Services, Inc. Supplies New C-Arm Inventory and Highly Qualified Professional Radiology Technologists to the Texas Institute for Medical Education (TIME) and Medical Education & Research Institute of Nevada (MERIN)
6. PCAN Calls On Federal Government to Reconsider Preliminary Approval of Texas Medicaid Waiver Request
7. MedInformatix Practice Management and Electronic Medical Records Simplifies Texas Dermatology Practices Current and Future Operations
8. Texas Childrens Hospital Explants Heart Assist Device: Sends Teen Home with a Healed Heart
9. Texas Childrens Hospital Pioneers Use of MRI-guided Laser Surgery for Revolutionary New Epilepsy Treatment
10. American Scientific Resources and School Health Corporation to Supply The Disintegrator™ Needle Destruction Device to Texas School District
11. Pharmacy Choice and Access Now Coalition Applauds Passage of Senate Bill 7 During Texas Legislatures Special Session
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/18/2017)... NEW YORK , January 18, 2017 ... perception of people regarding the use of cannabis both for ... not only are more Americans open to the use of ... and financial sectors. According to Arcview Market Research, the North ... 2016, up 30% from the previous year. The research projects ...
(Date:1/18/2017)... TOKYO , Jan. 18, 2017  Astellas ... , "Astellas" ) today announced its participation in ... access to non-communicable disease (NCD) prevention, diagnostics and ... with 21 other leading pharmaceutical companies and in ... Union for International Cancer Control (UICC), Astellas will ...
(Date:1/17/2017)... LONDON , Jan. 17, 2017 ... health and for the treatment of disease. The ... individual response to a therapy. The approach studies ... with their lifestyle and environment. In January 2015, ... precision medicine to all diseases with more than ...
Breaking Medicine Technology:
(Date:1/19/2017)... ... January 19, 2017 , ... Creative messages to prevent distracted ... from Impact Teen Drivers and California Casualty. Entries from students aged 14-22 can ... totaling $15,000 will be awarded for the best peer-to-peer messages sharing solutions to ...
(Date:1/19/2017)... (PRWEB) , ... January 19, 2017 , ... Connecticut Dermatology ... H. Kim, a highly experienced and compassionate dermatologist. Dr. Kim brings an extensive ... . , “It is with considerable pleasure to welcome back Dr. Kim to the ...
(Date:1/19/2017)... ... , ... Infinity® Massage Chairs announced today that Dan Grover has joined the ... Grover comes with a total of 15 years experience in consumer goods and an ... President of Direct Sales at Traeger® Wood Pellet Grills. , Grover has elevated ...
(Date:1/18/2017)... ... January 18, 2017 , ... A recent video posting of ... discussion about the benefits of fidgeting to relieve stress and anxiety. No one ... Their Think Ink Pen had just completed a successful Kickstarter campaign raising $67,000 on ...
(Date:1/18/2017)... ... 18, 2017 , ... The VA Maryland Health Care System ... research project focused on multiple sclerosis (MS). Led by Christopher M. Jewell, PhD, ... the disease without compromising normal immune function that often occurs during autoimmune diseases. ...
Breaking Medicine News(10 mins):