· Presentation: Pediatric Focused Safety Review for Berlin Heart (PDF - MB) Berlin Heart Instructions for Use, Rev. 8 (PDF - MB) Berlin Heart Physician's Manual v.4 (PDF - MB) Berlin. The EXCOR Pediatric system can support pediatric patients of all ages, from newborns to adolescents. The wide portfolio of pumps and cannulae allows Berlin Heart to meet the individual needs of each patient. Since , the EXCOR® Pediatric VAD has been successfully used in increasing numbers at pediatric heart centers in 37 countries. Briefing Materials. Berlin Heart Executive Summary Update, Presentation: Pediatric Focused Safety Review for Berlin Heart. Berlin Heart .
It is indicated for children with life-threatening heart failure after all conservative therapeutic options have been exhausted. EXCOR ® Pediatric is designed for use in young patients, from newborns to adolescents. Berlin Heart offers a comprehensive service plan for this system. The DeBakey VAD Child device and the Berlin Heart EXCOR Pediatric VAD have Food and Drug Administration approval through the humanitarian device exemption process. The DeBakey VAD is indicated for use in children ages 5 to 16 years who are awaiting a heart transplant (ie, a bridge to transplant) while the Berlin Heart EXCOR. The Berlin Heart EXCOR is the first Pediatric Ventricular Assist Device (VAD) to be awarded approval from the U.S Food and Drug Administration (FDA) in To date, the Berlin Heart has been used in approximately 1, children worldwide and is the only device of its kind available for babies and children with severe heart failure.
Registry to Monitor Berlin Heart EXCOR® Pediatric VAD as a Bridge to The registry Protocol and Manual of Operations will be followed by. 1 Jan Berlin Heart. EXCOR Pediatric VAD. Ventricular Assist Device with Stationary Driving Unit Ikus Rev. for Pediatric Use. Instructions for Use. 8 Feb In this study we examine the use of Berlin Heart EXCOR in CHD patients. Methods. CHD patients were identified from the EXCOR Pediatric Study.
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