• 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

    The Berlin Heart is the only device for use in babies and young kids

    HOUSTON - (Dec. 16. 2011) - 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.

    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.”

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