Berlin Heart Receives First Regulatory Approval in North America
...gulatory issues in Canada. The Berlin Heart excor Pediatric is a mechanical cardiac support system f...over and work on its own again. Unlike other VADs, excor Pediatric can be used to support children of all a...er 2007, 21 patients were supported in Canada with excor Pediatric under special access approval. Ab...National study will look at German-made heart pump for children needing heart transplants
...ta to the FDA for consideration of approval of the excor Pediatric VAD for use in the U.S. The Berlin Hear...t many pediatric heart patients. The Berlin Heart excor Pediatric VAD, which comes in graduated sizes to f...pleased to work with Dr. Fraser as the NPI for the excor Pediatric IDE trial, which is of great importance ...Children's Hospital leads projects to develop nation's first heart assist devices for young children
... on a case-by-case basis, approval from the FDA to implant the Berlin Heart excor for compassionate use. Five patients at Childrens have received Berlin Heart excor devices and gone on to receive successful heart transplants. This VAD, deve...500th Patient Receives Berlin Heart EXCOR Pediatric Ventricular Assist Device
BERLIN, May 28 /PRNewswire/ -- The 500th patient was supported with the Berlin Heart EXCOR(R) Pediatric Ventricular Assist Device (also known as the "Berlin Heart") since the first implantation of the device in 1990. The patient, an 11-month-old girl, received the device at the Children's Memo...Berlin Heart Inc. Receives FDA Orphan Product Development Grant
...to Heart Transplantation." The Berlin Heart excor Pediatric VAD is a system for mechanical support o...ients." About EXCOR(R) Pediatric The excor Pediatric Ventricular Assist Device is a mechanica...tric patients suffering from severe heart failure. excor Pediatric has been used in more than 500 pediatric...Berlin Heart Enrolls First Patient in US Multi-Center EXCOR(R) Pediatric VAD IDE Study
...cipal Investigator for the IDE study, congratulated the team at Arkansas Children's Hospital for proceeding with the first implant of the Berlin Heart excor Paediatric VAD as part of the IDE study: "The initiation of this study represents a giant step forward in the care of children with critical heart fai...