Berlin Heart's pediatric ventricular assist device given unconditional investigation device exemption approval by FDA.Berlin Heart, Inc., Berlin, Germany, announced its Excor Pediatric pediatric /pe·di·at·ric/ (pe?de-at´rik) pertaining to the health of children. pe·di·at·ric adj. Of or relating to pediatrics. ventricular assist device ventricular assist device: see under heart, artificial. (VAD) has received unconditional approval from the FDA for the ongoing Investigational Device Exemption An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and (IDE) in the US. In 2007, the FDA granted conditional approval for the prospective IDE study to begin initially at 10 centers with 10 patients, while the company addressed some questions the agency had found after reviewing the study design. The Berlin Heart Excor Pediatric is a mechanical support system for critically ill pediatric patients suffering from severe heart failure. The company says that unlike standard heart-lung machines, their system has been used as a short-term, mid-term, and long-term support system, supporting failing hearts from days up to several months. The system is designed to bridge patients awaiting heart transplantation until a donor heart becomes available, but it has also been used successfully as a bridge to recovery when a patient's heart was able to recover and work on its own again. The company also says unlike other VADs, the Excor Pediatric can be used to support children of all age groups, from newborns up to teenagers. The following US centers are participating in the IDE study: Arkansas Children's Hospital Arkansas Children's Hospital, an affiliate of the University of Arkansas for Medical Sciences, is the only pediatric medical center in Arkansas and one of the largest in the United States, serving children from birth to age 21. ; Boston Children's Hospital; Children's Hospital of Wisconsin; Lucille Packard Children's Hospital at Stanford (CA); Mott Children's Hospital (MI); Riley Children's Hospital (IN), Seattle Children's Hospital; St. Louis Children's Hospital St. Louis Children's Hospital is a pediatric hospital in St. Louis, Missouri, and is one of the premier children's hospitals in the United States. Children's Hospital is the pediatric teaching hospital for Washington University School of Medicine, ranked the 4th best medical school ; Texas Children's Hospital; Children's Hospital at the University of Alabama at Birmingham UAB began in 1936 as the Birmingham Extension Center of the University of Alabama. Because of the rapid growth of the Birmingham area, it was decided that an extension program for students who had difficulties which prevented them from studying in Tuscaloosa was needed. ; and the Children's Hospital at the University of Minnesota at Fairview. Contact: Web site - www.berlinheart.com |
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