96:
510:
Friedrich; Müller, Johannes; Nikolov, Dimitar; Rucinskas, Kestutis; Scheld, Hans-Heinrich; Schmid, Franz-Xaver; Schneider, Michael; Sirvydis, Vytautas; Tandler, René; Vitali, Ettore; Vlasselaers, Dirk; Weyand, Michael; Wilhelm, Markus; Hetzer, Roland (2008). "Influence of Inflow
Cannula Length in Axial-flow Pumps on Neurologic Adverse Event Rate: Results From a Multi-center Analysis".
553:
Fraser, Charles D.; Jaquiss, Robert D.B.; Rosenthal, David N.; Humpl, Tilman; Canter, Charles E.; Blackstone, Eugene H.; Naftel, David C.; Ichord, Rebecca N.; Bomgaars, Lisa; Tweddell, James S.; Massicotte, M. Patricia; Turrentine, Mark W.; Cohen, Gordon A.; Devaney, Eric J.; Pearce, F. Bennett;
509:
Schmid, Christof; Jurmann, Michael; Birnbaum, Dietrich; Colombo, Tiziano; Falk, Volkmar; Feltrin, Giuseppe; Garatti, Andrea; Genoni, Michele; Gerosa, Gino; Göttel, Peter; Gummert, Jan; Halfmann, Robert; Hammel, Dieter; Hennig, Ewald; Kaufmann, Friedrich; Lanfranconi, Marco; Meyns, Bart; Mohr,
131:). The EXCOR Pediatric device received full premarket approval (PMA) in the U.S. in 2017. Most recently, the EXCOR Active, a new mobile drive for the EXCOR ventricular assist device, was granted CE marking, affirming its compliance with European health, safety, and environmental standard.
169:
while floating contact free. Due to the rotation, up to eight liters of blood per minute are continuously pumped through the body. A percutaneous driveline connects the pump with the external controller. The control unit and the two batteries are carried in a shoulder-bag.
216:
In 2018 Chloe
Caldwell became the first pediatric patient to be flown for a medical treatment from the United States to Germany. Caldwell had been implanted a VAD manufactured by Berlin Heart after severe heart problems. A team of doctors at the Berlin's
109:
In 1987, the first EXCOR LVAD implantation was performed by Roland Hetzer at the German Heart Centre in Berlin. This pioneering procedure was followed in 1990 by the first paediatric EXCOR implantation at the same institution.
207:
The EXCOR product range covers blood pumps and cannula of various sizes and types. While EXCOR Adult is specifically designed for adults, EXCOR Pediatric includes devices for young patients (from newborns to adolescents).
192:. The movement of air in and out of the air chamber is controlled by a driving unit. It moves the membranes, which draw blood into the blood chamber and push it back into the body. Like the heart, EXCOR blood pumps have
246:
In 2008, the INCOR patient Jean-Pierre Offe celebrated his five-year anniversary while on the system and therefore setting an INCOR world record. EXCOR Pediatric received unrestricted IDE Approval in the
738:
117:
and was supported by private investors. Four years later, in 2000, Mediport
Kardiotechnik merged with its predecessor company, Mediport Kardiotechnik GmbH to form Berlin Heart AG.
607:
864:
937:
822:
785:
766:
836:
624:
Engin, C.; Ayik, F.; Oguz, E.; Eygi, B.; Yagdi, T.; Karakula, S.; Ozbaran, M. (2011). "Ventricular Assist Device as a Bridge to Heart
Transplantation in Adults".
903:
414:
127:
A significant change ocurred in 2006, when a private investor acquired Berlin Heart and changed its legal structure in 2006 to a limited liability company (
850:
752:
128:
492:
281:
Berlin Heart's headquarters is in Berlin, Germany, where all products and equipment are also manufactured. The wholly owned Berlin Heart, Inc. in
806:
180:
VAD. The device provides left ventricular, right ventricular or biventricular assistance. The EXCOR system includes paracorporeal,
87:
EXCOR VAD. To date, Berlin Heart produces the only device of its kind available for babies and children with severe heart failure.
602:
343:
95:
691:
667:
780:
113:
The company officially began operations as
Mediport Kardiotechnik GmbH in 1996, established by the German Heart Institute
221:(DHZB) removed the VAD successfully and she is expected to make a full recovery, without the need of a heart transplant.
218:
188:
blood pumps. Each pump consists of a blood chamber and an air chamber which are separated by a multilayer flexible
715:
374:
68:
390:"U.S. Food & Drug Administration (FDA): Premarket Approval (PMA), EXCOR Pediatric Ventricular Assist Device"
879:
389:
272:
In 2019, The new mobile drive for the heart support system Excor, the Excor Active, receives the CE marking.
201:
193:
487:
257:
approval for the U.S. market. The number of children who had been on EXCOR Pediatric reached over 1,000.
196:
which ensure that the blood only flows in one direction. The blood pumps are connected to the heart and
282:
153:. In this system, the pump is implanted directly next to the heart and is connected to the heart by
269:
In 2017, Excor
Pediatric receives full market approval (Premarket Approval, PMA) on the US market.
441:"First experiences with a novel magnetically suspended axial flow left ventricular assist device"
100:
80:
866:
The 1,500th child supported by the Berlin Heart ventricular assist device has been transplanted
801:
649:
641:
585:
577:
535:
527:
470:
462:
351:
150:
439:
Hetzer, R; Weng, Y; Potapov, E; Pasic, M; Drews, T; Jurmann, M; Hennig, E; Muller, J (2004).
633:
567:
519:
452:
320:"Deutsches Herzzentrum Berlin: Historie - Die Entwicklung des Deutschen Herzzentrums Berlin"
166:
162:
84:
120:
The expansion continued with the establishment of a U.S. subsidiary, Berlin Heart Inc., in
810:
789:
611:
496:
146:
243:
In 2003, INCOR received CE approval after successfully completing the Multi-Center Study.
637:
177:
931:
76:
260:
In 2012, the longest support time of a toddler on EXCOR Pediatric reached 2.5 years.
197:
185:
523:
614:. Washington University School of Medicine in St. Louis. Retrieved 25 June 2015.
457:
440:
301:
231:
181:
754:
Berlin Heart INCOR Implanted Blood Pump with
Carmeda Coating Receives CE Mark
645:
581:
531:
466:
355:
838:
1000th child to be supported with the Berlin Heart ventricular assist device
250:
In 2009, the 500th patient received INCOR VAD at the German Heart
Institute.
139:
Berlin Heart manufactures two types of VADs: implantable and paracorporeal.
653:
589:
539:
474:
319:
285:, provides support for implanting centers in the United States and Canada.
572:
555:
554:
Carberry, Kathleen E.; Kroslowitz, Robert; Almond, Christopher S. (2012).
768:
Heart
Patient Living With Implantable Heart Support System for Five Years
189:
852:
Longest support time with the EXCOR® Pediatric ventricular assist device
266:
In 2014, the 1,500th pediatric patient was supported by EXCOR Pediatric.
154:
114:
240:
In 2000, the first child in the USA is supported by EXCOR Pediatric.
792:. Diagnostic and Interventional Cardiology. Retrieved 25 June 2015.
263:
In 2013, the EXCOR Pediatric 15 ml blood pump received CE approval.
158:
121:
72:
254:
824:
Berlin Heart EXCOR® Pediatric
Ventricular Assist Device (VAD)
740:
Berlin Heart, Inc. EXCOR® Pediatric Ventricular Assist Device
827:. U.S. Food and Drug Administration. Retrieved 25 June 2015.
743:. U.S. Food and Drug Administration. Retrieved 25 June 2015.
556:"Prospective Trial of a Pediatric Ventricular Assist Device"
237:
In 1999, the EXCOR mobile driving unit received CE approval.
161:
coming from the heart flows into the INCOR axial pump. The
782:
Berlin Heart's EXCOR Pediatric VAD Approved for IDE Study
230:
In 1996, the EXCOR Stationary Driving Unit Ikus received
306:. Texas Children's Heart Center. Retrieved 25 June 2015.
67:
is a German company that develops, produces and markets
813:. Deutsches Herzzentrum Berlin. Retrieved 25 June 2015.
344:"Wirtschaft: Eine kleine Pumpe bringt Urlaub fĂĽrs Herz"
692:"Utah toddler flown to Germany for rare heart surgery"
668:"Utah toddler flown to Germany for rare heart surgery"
48:
40:
32:
24:
904:"Neue Möglichkeiten für schwer herzkranke Kinder"
415:"Neue Möglichkeiten für schwer herzkranke Kinder"
512:The Journal of Heart and Lung Transplantation
71:(VADs). The devices mechanically support the
8:
855:. Berlin Heart GmbH. Retrieved 25 June 2015.
841:. Berlin Heart GmbH. Retrieved 25 June 2015.
379:. Berlin Heart GmbH. Retrieved 25 June 2015.
19:
445:European Journal of Cardio-Thoracic Surgery
18:
571:
456:
757:. Business Wire. Retrieved 25 June 2015.
94:
938:Medical technology companies of Germany
294:
771:. PR Newswire. Retrieved 25 June 2015.
79:. Berlin Heart's products include the
105:in front of the Head Office in Berlin
7:
314:
312:
869:. Open PR. Retrieved 25 June 2015.
638:10.1016/j.transproceed.2011.01.147
253:In 2011, EXCOR Pediatric received
14:
716:"Mit Kunstherz ĂĽber den Atlantik"
499:. MyLVAD. Retrieved 25 June 2015.
560:New England Journal of Medicine
1:
910:(in German). 19 February 2020
524:10.1016/j.healun.2007.12.007
219:Deutsches Herzzentrum Berlin
626:Transplantation Proceedings
458:10.1016/j.ejcts.2004.02.038
75:of patients with end-stage
954:
880:"Premarket Approval (PMA)"
165:in the pump has an active
69:ventricular assist devices
36:Ventricular assist devices
720:nachrichten.idw-online.de
350:(in German). 1998-03-27.
28:Limited liability company
149:for support of the left
803:The History of the DHZB
421:(in German). 2020-02-19
348:Der Tagesspiegel Online
101:Buddy Bear Berlin Heart
884:www.accessdata.fda.gov
809:June 27, 2015, at the
788:June 27, 2015, at the
495:June 27, 2015, at the
394:www.accessdata.fda.gov
376:Berlin Heart - History
106:
573:10.1056/NEJMoa1014164
98:
16:German health company
283:the Woodlands, Texas
176:is a paracorporeal,
21:
908:www.berlinheart.de
610:2015-06-27 at the
489:Berlin Heart Incor
419:www.berlinheart.de
107:
83:INCOR VAD and the
65:Berlin Heart GmbH
62:
61:
945:
919:
918:
916:
915:
900:
894:
893:
891:
890:
876:
870:
862:
856:
848:
842:
834:
828:
820:
814:
799:
793:
778:
772:
764:
758:
750:
744:
736:
730:
729:
727:
726:
712:
706:
705:
703:
702:
688:
682:
681:
679:
678:
664:
658:
657:
621:
615:
604:VADs in Children
600:
594:
593:
575:
550:
544:
543:
506:
500:
485:
479:
478:
460:
436:
430:
429:
427:
426:
411:
405:
404:
402:
401:
386:
380:
372:
366:
365:
363:
362:
340:
334:
333:
331:
330:
316:
307:
303:Berlin Heart VAD
299:
167:magnetic bearing
22:
953:
952:
948:
947:
946:
944:
943:
942:
928:
927:
925:
923:
922:
913:
911:
902:
901:
897:
888:
886:
878:
877:
873:
863:
859:
849:
845:
835:
831:
821:
817:
811:Wayback Machine
800:
796:
790:Wayback Machine
779:
775:
765:
761:
751:
747:
737:
733:
724:
722:
714:
713:
709:
700:
698:
690:
689:
685:
676:
674:
666:
665:
661:
623:
622:
618:
612:Wayback Machine
601:
597:
552:
551:
547:
508:
507:
503:
497:Wayback Machine
486:
482:
438:
437:
433:
424:
422:
413:
412:
408:
399:
397:
388:
387:
383:
373:
369:
360:
358:
342:
341:
337:
328:
326:
318:
317:
310:
300:
296:
291:
279:
227:
214:
147:axial-flow pump
137:
104:
93:
58:
54:
17:
12:
11:
5:
951:
949:
941:
940:
930:
929:
921:
920:
895:
871:
857:
843:
829:
815:
794:
773:
759:
745:
731:
707:
683:
659:
632:(3): 927–930.
616:
595:
566:(6): 532–541.
545:
518:(3): 253–260.
501:
480:
451:(6): 964–970.
431:
406:
381:
367:
335:
308:
293:
292:
290:
287:
278:
275:
274:
273:
270:
267:
264:
261:
258:
251:
248:
244:
241:
238:
235:
226:
223:
213:
210:
178:pulsatile flow
136:
133:
92:
89:
60:
59:
56:
52:
50:
46:
45:
42:
38:
37:
34:
30:
29:
26:
15:
13:
10:
9:
6:
4:
3:
2:
950:
939:
936:
935:
933:
926:
909:
905:
899:
896:
885:
881:
875:
872:
868:
867:
861:
858:
854:
853:
847:
844:
840:
839:
833:
830:
826:
825:
819:
816:
812:
808:
805:
804:
798:
795:
791:
787:
784:
783:
777:
774:
770:
769:
763:
760:
756:
755:
749:
746:
742:
741:
735:
732:
721:
717:
711:
708:
697:
693:
687:
684:
673:
669:
663:
660:
655:
651:
647:
643:
639:
635:
631:
627:
620:
617:
613:
609:
606:
605:
599:
596:
591:
587:
583:
579:
574:
569:
565:
561:
557:
549:
546:
541:
537:
533:
529:
525:
521:
517:
513:
505:
502:
498:
494:
491:
490:
484:
481:
476:
472:
468:
464:
459:
454:
450:
446:
442:
435:
432:
420:
416:
410:
407:
395:
391:
385:
382:
378:
377:
371:
368:
357:
353:
349:
345:
339:
336:
325:
321:
315:
313:
309:
305:
304:
298:
295:
288:
286:
284:
276:
271:
268:
265:
262:
259:
256:
252:
249:
245:
242:
239:
236:
233:
229:
228:
224:
222:
220:
211:
209:
205:
203:
199:
198:blood vessels
195:
191:
187:
183:
182:pneumatically
179:
175:
171:
168:
164:
160:
156:
152:
148:
144:
140:
134:
132:
130:
125:
123:
118:
116:
111:
102:
97:
90:
88:
86:
85:paracorporeal
82:
78:
77:heart failure
74:
70:
66:
51:
47:
43:
39:
35:
31:
27:
23:
924:
912:. Retrieved
907:
898:
887:. Retrieved
883:
874:
865:
860:
851:
846:
837:
832:
823:
818:
802:
797:
781:
776:
767:
762:
753:
748:
739:
734:
723:. Retrieved
719:
710:
699:. Retrieved
695:
686:
675:. Retrieved
671:
662:
629:
625:
619:
603:
598:
563:
559:
548:
515:
511:
504:
488:
483:
448:
444:
434:
423:. Retrieved
418:
409:
398:. Retrieved
396:. 2017-06-06
393:
384:
375:
370:
359:. Retrieved
347:
338:
327:. Retrieved
323:
302:
297:
280:
215:
206:
186:polyurethane
173:
172:
142:
141:
138:
126:
119:
112:
108:
64:
63:
49:Headquarters
25:Company type
20:Berlin Heart
696:www.ksl.com
672:www.ksl.com
324:www.dhzb.de
232:CE approval
81:implantable
914:2022-08-26
889:2022-08-26
725:2018-12-14
701:2018-12-14
677:2018-12-14
425:2024-08-23
400:2024-08-23
361:2024-08-23
329:2024-08-23
289:References
225:Milestones
124:in 2005.
646:0041-1345
582:0028-4793
532:1053-2498
467:1010-7940
356:1865-2263
277:Locations
204:cannula.
151:ventricle
932:Category
807:Archived
786:Archived
654:21486630
608:Archived
590:22873533
540:18342745
493:Archived
475:15144996
202:silicone
190:membrane
184:-driven
135:Products
33:Industry
155:cannula
91:History
57:Germany
41:Founded
652:
644:
588:
580:
538:
530:
473:
465:
354:
212:Trivia
194:valves
157:. The
145:is an
115:Berlin
73:hearts
53:Berlin
174:EXCOR
163:rotor
159:blood
143:INCOR
122:Texas
650:PMID
642:ISSN
586:PMID
578:ISSN
536:PMID
528:ISSN
471:PMID
463:ISSN
352:ISSN
247:USA.
200:via
129:GmbH
44:2000
634:doi
568:doi
564:367
520:doi
453:doi
255:FDA
934::
906:.
882:.
718:.
694:.
670:.
648:.
640:.
630:43
628:.
584:.
576:.
562:.
558:.
534:.
526:.
516:27
514:.
469:.
461:.
449:25
447:.
443:.
417:.
392:.
346:.
322:.
311:^
55:,
917:.
892:.
728:.
704:.
680:.
656:.
636::
592:.
570::
542:.
522::
477:.
455::
428:.
403:.
364:.
332:.
234:.
103:'
99:'
Text is available under the Creative Commons Attribution-ShareAlike License. Additional terms may apply.
