Vendor:Berlin Heart GmbH

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Berlin Heart
Company typeLimited liability company
IndustryVentricular assist devices
Founded2000
Headquarters
Berlin
,
Germany

Berlin Heart GmbH is a German company that develops, produces and markets ventricular assist devices (VADs). The devices mechanically support the hearts of patients with end-stage heart failure. Berlin Heart's products include the implantable INCOR VAD and the paracorporeal EXCOR VAD. To date, Berlin Heart produces the only device of its kind available for babies and children with severe heart failure.[1]

History

'Buddy Bear Berlin Heart'
in front of the Head Office in Berlin

In 1987, the first EXCOR LVAD implantation was performed by Roland Hetzer at the German Heart Centre in Berlin.[2] This pioneering procedure was followed in 1990 by the first paediatric EXCOR implantation at the same institution.[2]

The company officially began operations as Mediport Kardiotechnik GmbH in 1996, established by the German Heart Institute Berlin and was supported by private investors.[3] Four years later, in 2000, Mediport Kardiotechnik merged with its predecessor company, Mediport Kardiotechnik GmbH to form Berlin Heart AG.

The expansion continued with the establishment of a U.S. subsidiary, Berlin Heart Inc., in Texas in 2005.

A significant change occurred in 2006, when a private investor acquired Berlin Heart and changed its legal structure in 2006 to a limited liability company (GmbH).[4] The EXCOR Pediatric device received full premarket approval (PMA) in the U.S. in 2017.[5] 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.[6]

Products

Berlin Heart manufactures two types of VADs: implantable and paracorporeal.

INCOR is an axial-flow pump for support of the left ventricle. In this system, the pump is implanted directly next to the heart and is connected to the heart by cannula. The blood coming from the heart flows into the INCOR axial pump.[7] The rotor in the pump has an active magnetic bearing while floating contact free.[8] 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.[9]

EXCOR is a paracorporeal, pulsatile flow VAD.[10] The device provides left ventricular, right ventricular or biventricular assistance.[11] The EXCOR system includes paracorporeal, pneumatically-driven polyurethane blood pumps. Each pump consists of a blood chamber and an air chamber which are separated by a multilayer flexible membrane.[12] 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 valves which ensure that the blood only flows in one direction. The blood pumps are connected to the heart and blood vessels via silicone cannula.

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).

Trivia

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.[13] A team of doctors at the Berlin's Deutsches Herzzentrum Berlin (DHZB) removed the VAD successfully and she is expected to make a full recovery, without the need of a heart transplant.[14][15]

Milestones

  • In 1996, the EXCOR Stationary Driving Unit Ikus received CE approval.
  • In 1999, the EXCOR mobile driving unit received CE approval.
  • In 2000, the first child in the USA is supported by EXCOR Pediatric.[16]
  • In 2003, INCOR received CE approval after successfully completing the Multi-Center Study.[17]
  • In 2008, the INCOR patient Jean-Pierre Offe celebrated his five-year anniversary while on the system and therefore setting an INCOR world record.[18] EXCOR Pediatric received unrestricted IDE Approval in the USA.[19]
  • In 2009, the 500th patient received INCOR VAD at the German Heart Institute.[20]
  • In 2011, EXCOR Pediatric received FDA approval for the U.S. market.[21] The number of children who had been on EXCOR Pediatric reached over 1,000.[22]
  • In 2012, the longest support time of a toddler on EXCOR Pediatric reached 2.5 years.[23]
  • In 2013, the EXCOR Pediatric 15 ml blood pump received CE approval.
  • In 2014, the 1,500th pediatric patient was supported by EXCOR Pediatric.[24]
  • In 2017, Excor Pediatric receives full market approval (Premarket Approval, PMA) on the US market.[25]
  • In 2019, The new mobile drive for the heart support system Excor, the Excor Active, receives the CE marking.[26]

Locations

Berlin Heart's headquarters is in Berlin, Germany, where all products and equipment are also manufactured. The wholly owned Berlin Heart, Inc. in the Woodlands, Texas, provides support for implanting centers in the United States and Canada.

References

  1. ^ Berlin Heart VAD. Texas Children's Heart Center. Retrieved 25 June 2015.
  2. ^ a b "Deutsches Herzzentrum Berlin: Historie - Die Entwicklung des Deutschen Herzzentrums Berlin". www.dhzb.de. Retrieved 2024-08-23.
  3. ^ "Wirtschaft: Eine kleine Pumpe bringt Urlaub fürs Herz". Der Tagesspiegel Online (in German). 1998-03-27. ISSN 1865-2263. Retrieved 2024-08-23.
  4. ^ Berlin Heart - History. Berlin Heart GmbH. Retrieved 25 June 2015.
  5. ^ "U.S. Food & Drug Administration (FDA): Premarket Approval (PMA), EXCOR Pediatric Ventricular Assist Device". www.accessdata.fda.gov. 2017-06-06. Retrieved 2024-08-23.
  6. ^ "Neue Möglichkeiten für schwer herzkranke Kinder". www.berlinheart.de (in German). 2020-02-19. Retrieved 2024-08-23.
  7. ^ Hetzer, R; Weng, Y; Potapov, E; Pasic, M; Drews, T; Jurmann, M; Hennig, E; Muller, J (2004). "First experiences with a novel magnetically suspended axial flow left ventricular assist device". European Journal of Cardio-Thoracic Surgery. 25 (6): 964–970. doi:10.1016/j.ejcts.2004.02.038. ISSN 1010-7940. PMID 15144996.
  8. ^ Berlin Heart Incor Archived June 27, 2015, at the Wayback Machine. MyLVAD. Retrieved 25 June 2015.
  9. ^ 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, 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". The Journal of Heart and Lung Transplantation. 27 (3): 253–260. doi:10.1016/j.healun.2007.12.007. ISSN 1053-2498. PMID 18342745.
  10. ^ 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; Carberry, Kathleen E.; Kroslowitz, Robert; Almond, Christopher S. (2012). "Prospective Trial of a Pediatric Ventricular Assist Device". New England Journal of Medicine. 367 (6): 532–541. doi:10.1056/NEJMoa1014164. ISSN 0028-4793. PMID 22873533.
  11. ^ VADs in Children Archived 2015-06-27 at the Wayback Machine. Washington University School of Medicine in St. Louis. Retrieved 25 June 2015.
  12. ^ 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". Transplantation Proceedings. 43 (3): 927–930. doi:10.1016/j.transproceed.2011.01.147. ISSN 0041-1345. PMID 21486630.
  13. ^ "Utah toddler flown to Germany for rare heart surgery". www.ksl.com. Retrieved 2018-12-14.
  14. ^ "Utah toddler flown to Germany for rare heart surgery". www.ksl.com. Retrieved 2018-12-14.
  15. ^ "Mit Kunstherz über den Atlantik". nachrichten.idw-online.de. Retrieved 2018-12-14.
  16. ^ Berlin Heart, Inc. EXCOR® Pediatric Ventricular Assist Device. U.S. Food and Drug Administration. Retrieved 25 June 2015.
  17. ^ Berlin Heart INCOR Implanted Blood Pump with Carmeda Coating Receives CE Mark. Business Wire. Retrieved 25 June 2015.
  18. ^ Heart Patient Living With Implantable Heart Support System for Five Years. PR Newswire. Retrieved 25 June 2015.
  19. ^ Berlin Heart's EXCOR Pediatric VAD Approved for IDE Study Archived June 27, 2015, at the Wayback Machine. Diagnostic and Interventional Cardiology. Retrieved 25 June 2015.
  20. ^ The History of the DHZB Archived June 27, 2015, at the Wayback Machine. Deutsches Herzzentrum Berlin. Retrieved 25 June 2015.
  21. ^ Berlin Heart EXCOR® Pediatric Ventricular Assist Device (VAD). U.S. Food and Drug Administration. Retrieved 25 June 2015.
  22. ^ 1000th child to be supported with the Berlin Heart ventricular assist device. Berlin Heart GmbH. Retrieved 25 June 2015.
  23. ^ Longest support time with the EXCOR® Pediatric ventricular assist device. Berlin Heart GmbH. Retrieved 25 June 2015.
  24. ^ The 1,500th child supported by the Berlin Heart ventricular assist device has been transplanted. Open PR. Retrieved 25 June 2015.
  25. ^ "Premarket Approval (PMA)". www.accessdata.fda.gov. Retrieved 2022-08-26.
  26. ^ "Neue Möglichkeiten für schwer herzkranke Kinder". www.berlinheart.de (in German). 19 February 2020. Retrieved 2022-08-26.


Notes

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