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The conventional approach has been to use extracorporeal membrane oxygenation (ECMO), but its lack of feasibility for long\u2010term use and the major complications associated with the technology have limited its use, especially in light of lengthy waiting lists for donor hearts. With the advent of the Berlin Heart EXCOR\u00ae Pediatric ventricular assist device (VAD), pediatric heart failure specialists have gained an important tool for helping this patient population survive until a donor heart can be identified. The EXCOR Pediatric VAD is designed to support pediatric patients of all age groups, from newborns to teenagers, and can be used successfully for many months. This paper describes the early experience with the EXCOR Pediatric VAD and the challenging journey undertaken to gain U.S. FDA approval, including successful completion of the first worldwide prospective clinical study of VADs in a pediatric population.<\/jats:p>","DOI":"10.1111\/nyas.12144","type":"journal-article","created":{"date-parts":[[2013,6,10]],"date-time":"2013-06-10T17:20:46Z","timestamp":1370884846000},"page":"96-105","source":"Crossref","is-referenced-by-count":23,"title":["The Berlin Heart EXCOR Pediatric ventricular assist device: history, North American experience, and future directions"],"prefix":"10.1111","volume":"1291","author":[{"suffix":"Jr.","given":"Charles D.","family":"Fraser","sequence":"first","affiliation":[{"name":"Texas Children's Hospital  Houston Texas"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Robert D.B.","family":"Jaquiss","sequence":"additional","affiliation":[{"name":"Duke Children's Hospital and Health Center Duke University School of Medicine  Durham North Carolina"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2013,6,10]]},"reference":[{"key":"e_1_2_8_2_1","unstructured":"Wikipedia.2013.Christiaan Barnard. 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