Berlin Heart Explained

Berlin Heart
Type:Limited liability company
Industry:Ventricular assist devices
Predecessors:-->
Successors:-->
Founded:2000
Founders:-->
Hq Location City:Berlin
Hq Location Country:Germany
Areas Served:-->
Owners:-->

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

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.

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

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.

Notes and References

  1. http://www.texaschildrens.org/Berlin-Heart/ Berlin Heart VAD
  2. Web site: Deutsches Herzzentrum Berlin: Historie - Die Entwicklung des Deutschen Herzzentrums Berlin . 2024-08-23 . www.dhzb.de.
  3. News: 1998-03-27 . Wirtschaft: Eine kleine Pumpe bringt Urlaub fürs Herz . 2024-08-23 . Der Tagesspiegel Online . de-DE . 1865-2263.
  4. http://www.berlinheart.de/index.php/unternehmen/content/unternehmen_geschichte Berlin Heart - History
  5. Web site: 2017-06-06 . U.S. Food & Drug Administration (FDA): Premarket Approval (PMA), EXCOR Pediatric Ventricular Assist Device . 2024-08-23 . www.accessdata.fda.gov.
  6. Web site: 2020-02-19 . Neue Möglichkeiten für schwer herzkranke Kinder . 2024-08-23 . www.berlinheart.de . de-DE.
  7. Hetzer . R . Weng . Y . Potapov . E . Pasic . M . Drews . T . Jurmann . M . Hennig . E . Muller . J . First experiences with a novel magnetically suspended axial flow left ventricular assist device . European Journal of Cardio-Thoracic Surgery . 25 . 6 . 2004 . 964–970 . 1010-7940 . 10.1016/j.ejcts.2004.02.038. free . 15144996 .
  8. http://mylvad.dev.digitalbungalow.com/lvad-devices/berlin-heart-incor Berlin Heart Incor
  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 . 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 . 2008 . 253–260 . 1053-2498 . 10.1016/j.healun.2007.12.007. 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. . Prospective Trial of a Pediatric Ventricular Assist Device . New England Journal of Medicine . 367 . 6 . 2012 . 532–541 . 0028-4793 . 10.1056/NEJMoa1014164 . 22873533. free .
  11. http://www.cardiothoracicsurgery.wustl.edu/en/Pediatric/Ventricular-Assist-Devices-in-Children VADs in Children
  12. Engin . C. . Ayik . F. . Oguz . E. . Eygi . B. . Yagdi . T. . Karakula . S. . Ozbaran . M. . Ventricular Assist Device as a Bridge to Heart Transplantation in Adults . Transplantation Proceedings . 43 . 3 . 2011 . 927–930 . 0041-1345 . 10.1016/j.transproceed.2011.01.147. 21486630 .
  13. Web site: Utah toddler flown to Germany for rare heart surgery. www.ksl.com. en. 2018-12-14.
  14. Web site: Utah toddler flown to Germany for rare heart surgery. www.ksl.com. en. 2018-12-14.
  15. Web site: Mit Kunstherz über den Atlantik. nachrichten.idw-online.de. 2018-12-14.
  16. https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/UCM263039.pdf Berlin Heart, Inc. EXCOR® Pediatric Ventricular Assist Device
  17. http://www.businesswire.com/news/home/20030508005418/en/Berlin-Heart-INCOR-Implanted-Blood-Pump-Carmeda#.VJlgGEPrA Berlin Heart INCOR Implanted Blood Pump with Carmeda Coating Receives CE Mark
  18. http://www.prnewswire.co.uk/news-releases/heart-patient-living-with-implantable-heart-support-system-for-five-years-154761605.html Heart Patient Living With Implantable Heart Support System for Five Years
  19. http://www.dicardiology.com/article/berlin-hearts-excor-pediatric-vad-approved-ide-study Berlin Heart's EXCOR Pediatric VAD Approved for IDE Study
  20. http://www.dhzb.de/en/about_us/the_dhzb/history_of_the_dhzb The History of the DHZB
  21. https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm302715.htm Berlin Heart EXCOR® Pediatric Ventricular Assist Device (VAD)
  22. http://www.berlinheart.de/UserFiles/File/pressemitteilungen-0103-file-PM_1_000ste_EXCOR_Pediatric_Implantation_2012_01_24_en.pdf 1000th child to be supported with the Berlin Heart ventricular assist device
  23. http://www.berlinheart.de/UserFiles/File/pressemitteilungen-0107-file-Longest_support_time_with_the_EXCOR_31.07.2012.pdf Longest support time with the EXCOR® Pediatric ventricular assist device
  24. http://www.openpr.com/news/309864/The-1-500th-child-supported-by-the-Berlin-Heart-ventricular-assist-device-has-been-transplanted.html The 1,500th child supported by the Berlin Heart ventricular assist device has been transplanted
  25. Web site: Premarket Approval (PMA) . 2022-08-26 . www.accessdata.fda.gov.
  26. Web site: Neue Möglichkeiten für schwer herzkranke Kinder . 2022-08-26 . www.berlinheart.de . 19 February 2020 . de-DE.

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